(10 days)
No
The device is a chemical indicator tape that changes color based on a chemical reaction, not through AI/ML processing. The description explicitly states it functions by means of a chemical reaction and there is no mention of AI, ML, or related concepts.
No
The device is a chemical indicator tape used to differentiate between processed and unprocessed loads in a sterilization system; it does not directly treat or diagnose any medical condition.
No
The device is a chemical indicator tape designed to show exposure to hydrogen peroxide in a sterilization system, not to diagnose a medical condition or disease in a patient. It differentiates between processed and unprocessed loads, which is a quality control function for sterilization, not a diagnostic one.
No
The device is a chemical indicator tape, which is a physical product that undergoes a chemical reaction to indicate exposure to hydrogen peroxide. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to secure sterilization packs and indicate exposure to hydrogen peroxide in a sterilization system. This is a process indicator for sterilization, not a diagnostic test performed on biological samples.
- Device Description: The description clearly states it's a "through-put process indicator tape" and its function is based on a chemical reaction to hydrogen peroxide, not on analyzing biological specimens.
- 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.
Therefore, the STERRAD® SealSure™ Chemical Indicator Tape falls under the category of a sterilization process indicator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
STERRAD® SealSure™ Chemical Indicator Tape is a process indicator intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization System.
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. Reference the color comparator bars on the package box label.
Product codes
JOJ
Device Description
STERRAD® SealSure™ Chemical Indicator Tape is a through-put process indicator tape to be used with ASP's STERRAD® Sterilization Systems. The STERRAD® Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low temperature sterilization of medical devices.
STERRAD® SealSure™ Chemical Indicator Tape is not intended to imply that sterilization has been achieved or to assure that the sterilization cycle has been completed. Rather, it provides a visual indication that hydrogen peroxide, an essential ingredient in the operation of the STERRAD® Sterilization Process, is present in the sterilization chamber.
STERRAD® SealSure™ Chemical Indicator Tape 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 gold (or lighter) STERRAD logos and chemical indicator square indicate 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
health care 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
Nonclinical Tests:
- Unopened package shelf life stability studies were conducted on samples of SealSure Chemical Indicator Tape to assess the color and functionality throughout the shelf life of the product. Based upon the results obtained, the study supports an extension of the unopened package shelf life to 22 months.
- Opened package shelf life stability studies were conducted on samples of SealSure Chemical Indicator Tape to assess the color and functionality throughout the shelf life of the product. Based upon the results obtained, the study supports an extension of the opened package shelf life to 5 months.
- Adhesion Strength studies were conducted on samples of SealSure Chemical Indicator Tape to assess the adhesive properties of the tape at the labeled shelf life for the product. Based upon the results obtained, the study confirms that the tape has adequate preprocessing and post-processing adhesive properties to support an extension of the product to 22 months.
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
ADVANCED STERILIZATION PRODUCTS®
a Johnson of chinen company REGULATORY AFFAIRS DEPARTMENT
K040742
510(k) Summary
Applicant's Name, Address, Telephone, FAX, Contact Person
Advanced Sterilization Products A Division of Johnson & Johnson Medical, Inc. 33 Technology Drive Irvine, CA 92618
Contact Person
Kevin Corrigan, R.A.C. Manager of Regulatory Affairs Tel: (949) 453-6410 Fax: (949) 789-3900
Natalie Bennington, R.A.C. Senior Regulatory Affairs Specialist Tel: (949) 453-6482 Fax: (949) 789-3900
Submission Date
March 22, 2004
Trade Name
STERRAD® SealSure™ Chemical Indicator Tape
Common Name
Chemical Sterilization Process Indicator
Classification Name
Class II
Legally Marketed Equivalent Device Name(s)
STERRAD® SealSure™ Chemical Indicator Tape, K022441, October 8, 2002.
DIVISION OF ETHICON, INC. . 33 TECHNOLOCY DRIVE . IRVINE, CA 92618 . (949) 581-5799 . FAX (949) 789-3908
1
Description of Device
STERRAD® SealSure™ Chemical Indicator Tape is a through-put process indicator tape to be used with ASP's STERRAD® Sterilization Systems. The STERRAD® Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low temperature sterilization of medical devices.
STERRAD® SealSure™ Chemical Indicator Tape is not intended to imply that sterilization has been achieved or to assure that the sterilization cycle has been completed. Rather, it provides a visual indication that hydrogen peroxide, an essential ingredient in the operation of the STERRAD® Sterilization Process, is present in the sterilization chamber.
STERRAD® SealSure™ Chemical Indicator Tape 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 gold (or lighter) STERRAD logos and chemical indicator square indicate that the load has been exposed to hydrogen peroxide.
Statement of Intended Use
STERRAD® SealSure™ Chemical Indicator Tape is a through put process indicator intended for use by health care 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. Reference the color comparator bars on the package box label.
Description of Modification
The modification is to the methods used to test the product for final release. Additionally, the labeling for the device was modified to reflect this release testing and to extend the shelf life of the device.
Summary of Nonclinical Tests
Unopened package shelf life stability studies were conducted on samples of SealSure Chemical Indicator Tape to assess the color and functionality throughout the shelf life of the product. Based upon the results obtained, the study supports an extension of the unopened package shelf life to 22 months.
Opened package shelf life stability studies were conducted on samples of SealSure Chemical Indicator Tape to assess the color and functionality throughout the shelf life of the product. Based upon the results obtained, the study supports an extension of the opened package shelf life to 5 months.
2
Special 510(k) Advanced Sterilization Products
Adhesion Strength studies were conducted on samples of SealSure Chemical Indicator Tape to assess the adhesive properties of the tape at the labeled shelf life for the product. Based upon the results obtained, the study confirms that the tape has adequate preprocessing and post-processing adhesive properties to support an extension of the product to 22 months.
Substantial Equivalence
The modified STERRAD® SealSure Chemical Indicator Tape has the following similarities to that which previously received 510(k) clearance:
- has the same intended use, .
- . have the same indicated use,
- . use the same operating principle,
- incorporate the same design, .
- . uses the same fundamental scientific technology,
- . incorporate the same materials and construction and
- is packaged using the same materials and processes. .
In summary, the STERRAD® SealSure Chemical Indicator Tape described in this submission is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wings.
APR - 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Sterilization Products Mr. Kevin Corrigan Manager of Regulatory Affairs A Division of Johnson & Johnson Medical, Incorporated 33 Technology Drive Irvine, California 92618
Re: K040742
Trade/Device Name: Modification to Sterrad® SealSure™ Chemical Indicator Tape Regulation Number: 880.2800 Regulation Name: Sterilization Process Indication Regulatory Class: II Product Code: JOJ Dated: March 22, 2004 Received: March 23, 2003
Dear Mr. Corrigan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Corrigan
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-5618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincercly yours,
Susan Runne
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
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Image /page/5/Picture/0 description: The image shows a logo with the letters "ASP" inside of a rounded rectangle. The letters are stylized, with the "A" being a triangle and the "S" and "P" being connected. To the right of the logo are the letters "A".
ADVANCED STERILIZATION PRODUCTS® a Johnona Johnson company REGULATORY AFFAIRS DEPARTMENT
Indications for Use
510(k) Number:
STERRAD® SealSure™ Chemical Indicator Tape
Indications For Use:
Device Name
STERRAD® SealSure™ Chemical Indicator Tape is a process indicator intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization System.
The color of the STERRAD® SealSure™ Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen pcroxide and is intended to differentiate between processed and unprocessed loads. Reference the color comparator bars on the package box label.
Prescription Use
OR
Over-the-Counter Use X'
(Optional Format 1-2-96)
Susan Runo
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: K0110742