STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count)
Device Facts
| Record ID | K234084 |
|---|---|
| Device Name | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count) |
| Applicant | Advanced Sterilization Products, Inc. |
| Product Code | JOJ · General Hospital |
| Decision Date | Jul 5, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2800 |
| Device Class | Class 2 |
Intended Use
The STERRAD™ Chemical Indicator (Cl) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems: . STERRAD™ 100S Sterilization System . STERRAD NX™ Sterilization System o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology o . STERRAD™ 100NX Sterilization System o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology o ULTRA GI™ Cycle with Integrated ALLClear Technology o
Device Story
The STERRAD Chemical Indicator (CI) Strip is a through-put process indicator used in STERRAD hydrogen peroxide gas plasma sterilization systems. It consists of a white styrene strip printed with chemically reactive ink, a clear overcoat, and a yellow comparator bar. When exposed to hydrogen peroxide, the ink undergoes an N-oxidation of tertiary amine reaction, changing from red to yellow (or lighter) to match the comparator bar. It is used by healthcare providers to differentiate processed from unprocessed packages. It does not confirm sterilization achievement. The device is single-use and intended for OTC use. It provides visual confirmation of hydrogen peroxide presence in the chamber, aiding in load management and reducing the risk of using unsterilized equipment.
Clinical Evidence
Bench testing only. Studies verified chemical indicator functionality, residual biocompatibility, and color stability post-processing in the ULTRA GI cycle. Biological indicator performance was validated via dose-response studies and fluorescence accuracy (BI fluorescence-positive for >97% of growth-positive BIs).
Technological Characteristics
Through-put process indicator; chemical reaction via N-oxidation of tertiary amine. Materials: white styrene (strip), polypropylene/Buna-N (PCD vial). Sensing: color change (red to yellow/gold) via hydrogen peroxide exposure. BI/Reader: Geobacillus stearothermophilus (ATCC 7953) spores, glass fiber carrier, fluorescence detection via UV LED/photodiode. Software: Reader version 1139260417 or newer. Sterilization: Hydrogen peroxide gas plasma.
Indications for Use
Indicated for use as a Type 1 process indicator to differentiate processed from unprocessed medical device packages in STERRAD 100S, STERRAD NX (Standard/Advanced cycles), and STERRAD 100NX (Standard, Flex, Express, Duo, and ULTRA GI cycles) sterilization systems. Not indicated for steam or ethylene oxide cycles.
Regulatory Classification
Identification
Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.
Predicate Devices
- STERRAD® Chemical Indicator Strip (K111518)
- STERRAD® SEALSURE® Chemical Indicator Tape (K111519)
- STERRAD VELOCITY® Biological Indicator/Process Challenge Device (BI/PCD) and STERRAD VELOCITY® Reader (K192025)
Related Devices
- K103218 — STERRAD CHEMICAL INDICATOR STRIP · Advanced Sterilization Products · Apr 1, 2011
- K111518 — STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 · Advanced Sterilization Products · Oct 3, 2012
- K030680 — SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR · Spsmedical Supply Corp. · May 9, 2003
- K103219 — STERRAD SEALSURE CHEMICAL INDICATOR TAPE · Advanced Sterilization Products · Apr 1, 2011
- K972300 — CROSS-CHECKS P · Steritec Products Mfg Co, Inc. · Mar 25, 1998
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
July 5, 2024
Advanced Sterilization Products, Inc. Brandon Roberts Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92618
## Re: K234084
Trade/Device Name: STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (60 count) (43210); STERRAD VELOCITY™ Biological Indicator (BI) (30 count) (43210-30): STERRAD VELOCITY™ Reader (43220): ULTRA GITM Process Challenge Device (PCD) Vial (30 count) (43400) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ, FRC Dated: December 22, 2023 Received: June 7, 2024
Dear Brandon Roberts:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
{2}------------------------------------------------
Sincerely, Christopher K. Dugard -2
Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) Number (if known) K234084
Device Name
STERRAD™ Chemical Indicator (CI) Strip (14100)
#### Indications for Use (Describe)
The STERRAD™ Chemical Indicator (CI) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems:
- · STERRAD™ 100S Sterilization System
- · STERRAD NXTM Sterilization System
o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
- · STERRAD™ 100NX Sterilization System
- o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology o ULTRA GITM Cycle with Integrated ALLClear Technology
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
{4}------------------------------------------------
510(k) Number (if known) K234084
#### Device Name
STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape (14202NL)
Indications for Use (Describe)
STERRAD™ SEALSURE™ Chemical Indicator Tape is a process indicator (ISO 11140-1:2014 [Type 1]) intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD™ Sterilization Systems:
· STERRAD™ 100S Sterilization System
· STERRAD NXTM Sterilization System
o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
- · STERRAD™ 100NX Sterilization System
o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology o ULTRA GI™ Cycle with Integrated ALLClear™ Technology
The color of the STERRAD SEALSURE Chemical Indicator Tape changes from red to gold (or lighter) indicated by comparator bar when exposed to hydrogen peroxide and is intended to differentiate between processed loads.
Type of Use (Select one or both, as applicable)
| <input type="checkbox"/> Residential Use (Per 24 CFR 982.305) Primary Residence | <input checked="" type="checkbox"/> Rent To Owner (Per 24 CFR 982.305) Primary Residence |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
{5}------------------------------------------------
#### 510(k) Number (if known) K234084
#### Device Name
STERRAD VELOCITY™ Biological Indicator (BI) (60 count) (43210); STERRAD VELOCITY™ Biological Indicator (BI) (30 count) (43210-30); STERRAD VELOCITY™ Reader (43220)
Indications for Use (Describe)
The STERRAD VELOCITY™ Biological Indicator (BI)/Process Challenge Device (PCD), in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring and/or periodic testing of the following STERRAD™ Systems:
· STERRAD™ 100NX Sterilization System
o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
o ULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only).
- · STERRAD NXTM Sterilization System
o (STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology
· STERRAD™ 100S Sterilization System
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
{6}------------------------------------------------
510(k) Number (if known) K234084
#### Device Name
ULTRA GITM Process Challenge Device (PCD) Vial (43400) (30 count)
Indications for Use (Describe)
The ULTRA GI™ Process Challenge Device (PCD) Vial is used with the STERRAD VELOCITY™ Biological Indicator (BI) for periodic testing and frequent monitoring of the ULTRA GI™ Cycle in the STERRAD™ 100NX Sterilization System with ALLClear™ Technology.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
{7}------------------------------------------------
# 510(k) Summary for K234084 Advanced Sterilization Products, Inc. STERRAD™ Chemical Indicator (CI) Strip
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
### General Information
| Submitter Name: | Advanced Sterilization Products, Inc. |
|----------------------|----------------------------------------------------|
| Address: | 33 Technology Drive |
| | Irvine, CA 92618 |
| Contact Person: | Brandon Roberts |
| | Senior Regulatory Affairs Specialist |
| | Phone: (323) 590-4214 |
| | Email: brandon.roberts@asp.com |
| Date Prepared: | July 2, 2024 |
| Device Name | |
| Proprietary Name: | STERRAD™ Chemical Indicator (CI) Strip (14100) |
| Common Name: | Chemical Sterilization Process Indicator Strip |
| Classification Name: | Indicator, Physical/Chemical Sterilization Process |
| Device Class: | Class II |
| Product Code: | JOJ |
| CFR Section: | 21 CFR 880.2800 |
### Predicate Device
STERRAD® Chemical Indicator Strip cleared under 510(k) K111518 on October 3, 2012.
{8}------------------------------------------------
### Device Description
The STERRAD™ Chemical Indicator (Cl) Strip consists of chemically reactive ink, a clear overcoat ink, a yellow comparator bar, and black ink for copy printed on a strip of white styrene. This device is a through-put process indicator 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. When in the presence of hydrogen peroxide, the indicator will change from red to yellow as indicated by the comparator bar to indicate that the load has been exposed to hydrogen peroxide.
The STERRAD Chemical Indicator (CI) Strip does not 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 System sterilization process, is present in the sterilization chamber.
## Intended Use/Indications For Use
The STERRAD™ Chemical Indicator (Cl) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems:
- . STERRAD™ 100S Sterilization System
- . STERRAD NX™ Sterilization System
- STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology o
- . STERRAD™ 100NX Sterilization System
- o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology
- ULTRA GI™ Cycle with Integrated ALLClear Technology o
| Device Characteristics | Subject Device | Predicate Device |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| | STERRAD™ Chemical Indicator<br>Strip (K234084) | STERRAD® Chemical Indicator<br>Strip (K111518) |
| Intended Use | The STERRAD™ Chemical<br>Indicator (CI) Strip is a process<br>indicator that is intended to<br>differentiate processed from<br>unprocessed packages and is<br>intended for use with medical<br>device packages to be<br>sterilized in STERRAD™<br>Sterilization Systems. | Same |
| Indications for Use | The STERRAD™ Chemical<br>Indicator (CI) Strip is a process<br>indicator per ISO 11140-1:2014<br>[Type ] (to differentiate<br>processed from unprocessed | The STERRAD® Chemical<br>Indicator Strip (PN 14100) is a<br>process indicator (ISO 11140-<br>1:2005) to differentiate<br>processed from unprocessed |
### Comparison of Technological Characteristics
{9}------------------------------------------------
| Device Characteristics | Subject Device | Predicate Device | | | | | | | | | | | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| | STERRAD™ Chemical Indicator<br>Strip (K234084)<br>packages) and is intended for<br>use with medical device<br>packages to be sterilized in the<br>following STERRAD™<br>Sterilization Systems:<br>STERRAD™ 100S<br>Sterilization System STERRAD NX™<br>Sterilization System STANDARD AND<br>ADVANCED<br>Cycles with and<br>without<br>ALLClear™<br>Technology STERRAD™ 100NX<br>Sterilization System STANDARD,<br>FLEX, EXPRESS,<br>and DUO Cycles<br>with and<br>without<br>ALLClear<br>Technology ULTRA GI™<br>Cycle with<br>Integrated<br>ALLClear<br>Technology | STERRAD® Chemical Indicator<br>Strip (K111518)<br>packages and is intended for<br>use with medical device<br>packages to be sterilized in<br>STERRAD® Sterilization<br>Systems:<br>MODEL CYCLE STERRAD®<br>100S Standard STERRAD®<br>50 Standard STERRAD®<br>200 Standard STERRAD®<br>NX® Standard<br>Advanced STERRAD®<br>100NX® Standard<br>Flex<br>Express<br>DUO | | | | | | | | | | | | |
| Contraindications | None | Same | | | | | | | | | | | | |
| Precautions | 1. Do not use after the<br>expiration date.<br>2. STERRAD CI Strip is not<br>indicated for use with<br>steam or ethylene oxide<br>sterilization cycles.<br>3. If the indicator bar has<br>not completely changed<br>from red to yellow (or<br>lighter) indicated by the<br>comparator bar, | Same | | | | | | | | | | | | |
{10}------------------------------------------------
| Device Characteristics | Subject Device | Predicate Device |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| | STERRAD™ Chemical Indicator<br>Strip (K234084) | STERRAD® Chemical Indicator<br>Strip (K111518) |
| | introduction of hydrogen<br>peroxide, an essential<br>component of the<br>STERRAD Sterilization<br>Cycle, may not have<br>taken place.<br>4. Single use only. Do not<br>reuse as the Chemical<br>Indicator Strip will not<br>function as intended if<br>reused. | |
| Regulation/Product Code | 880.2800 /JOJ | Same |
| Technology | Through-put process indicator | Same |
| Device Design: Functionality | Strip with Chemical Indicator | Same |
| Device Design: Chemical<br>Reaction | N-Oxidation of tertiary amine in<br>the presence of hydrogen<br>peroxide. | Same |
| Device Design: Cycle Parameter<br>Indication | Hydrogen Peroxide | Same |
| Device Design | Indicator bar changes from red<br>to yellow (or lighter) as<br>indicated by comparator bar<br>when exposed to<br>hydrogen peroxide. | Same |
| Distinct Color Change | Red (pre-processed) to yellow<br>or lighter (post-processed) as<br>indicated by comparator bar. | Same |
| Endpoint Color | Yellow or lighter as indicated<br>by comparator bar (Pantone<br>Color Formula Guide 144C). | Same |
| Single Use | Yes | Same |
| Over the Counter Use Device | Yes | Same |
| Packaging | Four cartons per shipper box<br>with each carton consisted of<br>250 strips placed in a<br>polyethylene bag. | Same |
{11}------------------------------------------------
| Performance Testing | Description | Acceptance Criteria | Pass/Fail |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Chemical Indicator<br>Functionality | This study verified the<br>Chemical Indicator<br>functionality after<br>processing in the ULTRA<br>GI Cycle. | The Chemical Indicator<br>will not change color<br>when not exposed to<br>the cycle parameter<br>indication.<br>The Chemical Indicator<br>will change color when<br>exposed to cycle<br>parameter indication. | Pass |
| Residual<br>Biocompatibility | This study<br>demonstrated the<br>biocompatibility of the<br>Chemical Indicator post<br>processing in the ULTRA<br>GI Cycle. | The residual hydrogen<br>peroxide level shall be<br>below the LOQ and<br>exhibit mild toxicity or<br>lower. | Pass |
| End Point /Post<br>Processing Color<br>Stability | This study<br>demonstrated that the<br>Chemical Indicator will<br>perform to the Type 1<br>requirements of ISO<br>11140-1:2014. | The chemical indicator<br>shall perform to the<br>Type 1 requirements of<br>ISO 11140-1:2014. | Pass |
#### Summary of Non-Clinical Testing
### Summary
The subject device, STERRAD Chemical Indicator (CI) Strip (14100), and its predicate utilize the same technology and verification/validation methods to achieve its intended use. The performance testing results indicate that including the ULTRA GI Cycle does not raise any new questions of safety or effectiveness. ASP believes the subject device to be as safe and effective as the predicate.
### Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the existing legally marketed predicate device, K111518.
{12}------------------------------------------------
# 510(k) Summary for K234084 Advanced Sterilization Products, Inc. STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
### General Information
| Submitter Name: | Advanced Sterilization Products, Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| Address: | 33 Technology Drive<br>Irvine, CA 92618 |
| Contact Person: | Brandon Roberts<br>Senior Regulatory Affairs Specialist<br>Phone: (323) 590-4214<br>Email: brandon.roberts@asp.com |
| Date Prepared: | July 2, 2024 |
| Device Name | |
| Proprietary Name: | STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape<br>(14202NL) |
| Common Name: | Chemical Sterilization Process Indicator Tape |
| Classification Name: | Indicator, Physical/Chemical Sterilization Process |
| Device Class: | Class II |
| Product Code: | JOJ |
| CFR Section: | 21 CFR 880.2800 |
### Predicate Device
STERRAD® SEALSURE® Chemical Indicator Tape cleared under 510(k) K111519 on October 3, 2012.
{13}------------------------------------------------
#### Device Description
The STERRAD™ SEALSURE™ Chemical Indicator Tape is a through-put process indicator tape to be used with ASP's STERRAD™ Sterilization Systems that utilize hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices.
The Chemical Indicator Tape reacts with hydrogen peroxide as it is introduced into the sterilization chamber. The chemical reaction between the indicator ink and the hydrogen peroxide causes the dye of the indicator ink on the diagonal STERRAD logos and the chemical indicator square on the tape to change color, indicating that the load has been exposed to hydrogen peroxide.
STERRAD SEALSURE Chemical Indicator Tape does not imply that sterilization has been achieved or to assure that the sterilization cycle has been completed.
### Intended Use/Indications For Use
STERRAD™ SEALSURE™ Chemical Indicator Tape is a process indicator (ISO 11140-1:2014 [Type 1]) intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD™ Sterilization Systems:
- STERRAD™ 100S .
- STERRAD NX™ .
- STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
- . STERRAD™ 100NX
- STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
- ം
The color of the STERRAD SEALSURE Chemical Indicator Tape changes from red to gold (or lighter) indicated by comparator bar when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.
| Device<br>Characteristics | Subject Device | Predicate Device |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | STERRAD™ SEALSURE™ Chemical<br>Indicator (CI) Tape (K234084) | STERRAD® SEALSURE® Chemical<br>Indicator Tape (K111519) |
| Intended Use | STERRAD SEALSURE Chemical<br>Indicator (CI) Tape is a process<br>indicator intended for use by<br>healthcare providers to secure non-<br>woven sterilization packs and wraps to<br>be sterilized in the STERRAD<br>Sterilization Systems. | Same |
#### Comparison of Technological Characteristics
{14}------------------------------------------------
| Device<br>Characteristics | Subject Device | Predicate Device | | | | | | | | | | | | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| Indications for<br>Use | STERRAD™ SEALSURE™ Chemical<br>Indicator (CI) Tape (K234084)<br><br>STERRAD™ SEALSURE™ Chemical<br>Indicator Tape is a process indicator<br>(ISO 11140-1:2014 [Type 1]) intended<br>for use by health care providers to<br>secure non-woven sterilization packs<br>and wraps to be sterilized in the<br>STERRAD™ Sterilization Systems:<br>STERRAD™ 100S STERRAD NX™ STANDARD AND<br>ADVANCED Cycles with<br>and without ALLClear™<br>Technology STERRAD™ 100NX STANDARD, FLEX,<br>EXPRESS, and DUO<br>Cycles with and<br>without ALLClear™<br>Technology ULTRA GI™ Cycle with<br>Integrated ALLClear™<br>Technology The color of the STERRAD SEALSURE<br>Chemical Indicator Tape changes<br>from red to gold (or lighter) indicated<br>by comparator bar when exposed to<br>hydrogen peroxide and is intended to<br>differentiate between processed and<br>unprocessed loads. | STERRAD® SEALSURE® Chemical<br>Indicator Tape (K111519)<br><br>STERRAD® SEALSURE® Chemical<br>Indicator Tape (PN 14202) is a process<br>indicator (ISO 11140-1:2005) intended<br>for use by healthcare providers to<br>secure non-woven sterilization packs<br>and wraps to be sterilized in the<br>STERRAD® Sterilization Systems.<br>MODELCYCLE STERRAD®<br>100SStandard STERRAD®<br>50Standard STERRAD®<br>200Standard STERRAD®<br>NXStandard<br>Advanced STERRAD®<br>100NXStandard<br>Flex<br>Express<br>DUO The color of the STERRAD® SEALSURE®<br>Chemical Indicator Tape changes from<br>red to gold (or lighter) when exposed<br>to hydrogen peroxide and is intended<br>to differentiate between processed and<br>unprocessed loads. | | | | | | | | | | | | |
| Precaution | None | This product contains dry natural<br>rubber. | | | | | | | | | | | | |
| Type of Chemical<br>Indicator | Through-put process indicator | Same | | | | | | | | | | | | |
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| Device | Subject Device | Predicate Device |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Characteristics | STERRAD™ SEALSURE™ Chemical<br>Indicator (CI) Tape (K234084) | STERRAD® SEALSURE® Chemical<br>Indicator Tape (K111519) |
| Chemical<br>Reaction | Oxidation-reduction reaction<br>specifically designed to react in the<br>presence of hydrogen peroxide. The<br>reaction is not reversible. | Same |
| Packaging | Six individually wrapped rolls per<br>shipper box. | Same |
| Design | STERRAD System logo / CI square<br>changes from red to gold (or lighter)<br>upon exposure to the sterilant,<br>hydrogen peroxide. | Same |
| Distinct Color<br>Change | Red (pre-processed) to gold or lighter<br>(post-processed) | Same |
| Single Use Device | Yes | Same |
## Summary of Non-Clinical Testing
| Performance Testing | Description | Acceptance Criteria | Pass/Fail |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Chemical Indicator<br>Functionality | This study verified the<br>Chemical Indicator<br>functionality after<br>processing in the ULTRA<br>GI Cycle. | The Chemical Indicator<br>will not change color<br>when not exposed to<br>the cycle parameter<br>indication.<br>The Chemical Indicator<br>will change color when<br>exposed to cycle<br>parameter indication. | Pass |
| Residual<br>Biocompatibility | This study<br>demonstrated the<br>biocompatibility of the<br>Chemical Indicator post<br>processing in the ULTRA<br>GI Cycle. | The residual hydrogen<br>peroxide level shall be<br>below the LOQ and<br>exhibit mild toxicity or<br>lower. | Pass |
| End Point /Post<br>Processing Color<br>Stability | This study<br>demonstrated that the<br>Chemical Indicator<br>perform to the Type 1 | The chemical indicator<br>shall perform to the<br>Type 1 requirements of<br>ISO 11140-1:2014. | Pass |
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| | requirements of ISO<br>11140-1:2014. | | |
|------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------|
| | | | |
| Tape Adhesion Strength | This study verifies the<br>adhesive strength after<br>processing in the ULTRA<br>GI Cycle. | The peel strength<br>(adhesion-strength)<br>must meet the<br>acceptance criteria. | Pass |
### Summary
The subject device, STERRAD SEALSURE Chemical Indicator (Cl) Tape (14202NL), and its predicate utilize the same technology and verification/validation methods to achieve the intended use. The performance testing results indicate that including the ULTRA GI Cycle does not raise any new questions of safety or effectiveness. ASP believes the subject device to be as safe and effective as the predicate.
## Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the existing legally marketed predicate device, K111519.
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# 510(k) Summary for K234084 Advanced Sterilization Products, Inc. STERRAD VELOCITY™ Biological Indicator (BI) and STERRAD VELOCITY™ Reader
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| General Information | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name: | Advanced Sterilization Products, Inc. |
| Address: | 33 Technology Drive<br>Irvine, CA 92618 |
| Contact Person: | Brandon Roberts<br>Senior Regulatory Affairs Specialist<br>Phone: (323) 590-4214<br>Email: brandon.roberts@asp.com |
| Date Prepared: | July 2, 2024 |
| Device Name | |
| Proprietary Name: | STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count), STERRAD<br>VELOCITY™ Biological Indicator (BI) (43210-30) (30 count) and STERRAD<br>VELOCITY™ Reader (43220) |
| Common Name: | Biological Indicator |
| Classification Name: | Indicator, Biological Sterilization Process |
| Device Class: | Class II |
| Product Code: | FRC |
| CFR Section: | 21 CFR 880.2800 |
### Predicate Device
STERRAD VELOCITY® Biological Indicator/Process Challenge Device (BI/PCD) and STERRAD VELOCITY® Reader cleared under 510(k) K192025 on January 23, 2020.
{18}------------------------------------------------
#### Device Description
The STERRAD VELOCITY Biological Indicator (BI) is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and/or periodic testing in STERRAD Sterilization Systems.
#### Intended Use/Indications For Use
The STERRAD VELOCITY™ Biological Indicator (BI)/Process Challenge Device (PCD), in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring and/or periodic testing of the following STERRAD™ Systems:
- . STERRAD™ 100NX Sterilization System
- STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
- ULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only). o
- . STERRAD NX™ Sterilization System
- (STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology
- . STERRAD™ 100S Sterilization System
| Device<br>Characteristics | Subject Device | Predicate Device |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | STERRAD VELOCITY™ BI and STERRAD<br>VELOCITY™ Reader (K234084) | STERRAD VELOCITY™ BI/PCD and<br>Reader (K192025) |
| | Monitoring of hydrogen peroxide gas<br>plasma sterilization processes. | Same |
| Indications for Use | The STERRAD VELOCITY™ Biological<br>Indicator (BI)/Process Challenge Device<br>(PCD), in conjunction with the STERRAD<br>VELOCITY™ Reader, is intended to be<br>used as a standard method for frequent<br>monitoring and/or periodic testing of<br>the following STERRAD™ Systems:<br>• STERRAD™ 100NX Sterilization<br>System<br>• STANDARD, FLEX,<br>EXPRESS, and DUO<br>Cycles with and without<br>ALLClear™ Technology<br>• ULTRA GI™ Cycle with<br>Integrated ALLClear<br>Technology (for | STERRAD VELOCITY® Biological<br>Indicator/Process Challenge Device, in<br>conjunction with the STERRAD VELOCITY<br>Reader, is intended to be used as a<br>standard method for frequent<br>monitoring and periodic testing of the<br>following STERRAD Sterilization Systems:<br>• STERRAD® IOONX (STANDARD,<br>FLEX, EXPRESS, and DUO<br>Cycles) with and without<br>ALLClear® Technology<br>• STERRAD NX® (STANDARD and<br>ADVANCED Cycles) with and<br>without ALLClear® Technology<br>• STERRAD 100S |
| | Subject Device | Predicate Device |
| Device<br>Characteristics | STERRAD VELOCITY™ BI and STERRAD<br>VELOCITY™ Reader (K234084)<br>frequent monitoring<br>only).<br>• STERRAD NX™ Sterilization<br>System<br>o (STANDARD AND<br>ADVANCED Cycles) with<br>and without ALLClear™<br>Technology<br>• STERRAD™ 100S Sterilization<br>System | STERRAD VELOCITY™ BI/PCD and<br>Reader (K192025) |
| Organism<br>(Spore, Species,<br>Strain) | Geobacillus stearothermophilus<br>ATCC 7953 | Same |
| Viable Spore<br>Population | $\ge$ 1x106 CFU/BI | Same |
| Carrier Material | Glass Fiber | Same |
| Device Design | Self-contained biological indicator. | Same |
| Resistance<br>Characteristics | • Tested at 5 mg/L hydrogen peroxide:<br>D-value 5mg/L: $\ge$ 1 second, using two<br>D-value methods (Survivor Curve and<br>Fraction Negative) per ISO 11138-1.<br>• Equal to or greater than the most<br>difficult item routinely processed<br>(biological model). | Same |
| Rapid Readout<br>Technology | The α-glucosidase enzyme system is<br>generated naturally during the growth<br>of Geobacillus stearothermophilus. The<br>α-glucosidase enzyme in its active state<br>is detected by measuring the<br>fluorescence produced by the enzymatic<br>hydrolysis of a non-fluorescent<br>substrate. The resultant fluorescent by-<br>product is detected in the reader. The<br>fluorescence signal is used to determine<br>a positive or negative result. | Same |
| Incubation<br>Temperature | 57 +/- 2°C | Same |
| Incubation Time | 15-minute fluorescence results read in | Same |
| | Subject Device | Predicate Device |
| Device<br>Characteristics | STERRAD VELOCITY™ BI and STERRAD<br>VELOCITY™ Reader (K234084) | STERRAD VELOCITY™ BI/PCD and<br>Reader (K192025) |
| | visual pH color change results at 5 to 7<br>days. | |
| Holding Time | Within 2 hours after sterilization cycle | Same |
| Carrier growth<br>inhibition/media<br>growth promotion | No bacteriostatic effects that inhibit the<br>growth of the indicator microorganism | Same |
| Chemical Indicator | Type 1 process indicator changes color<br>from red/pink to yellow or yellow with<br>some red/orange/brown dots to<br>indicate exposure to hydrogen peroxide. | Same |
| Method of<br>Fluorescence<br>Detection | UV LED, optical filters, with sensing by<br>photodiode | Same |
| Indicator of<br>Adequate<br>Sterilization Cycle | "Negative" displayed on LCD Display | Same |
| Indicators of<br>Possible Sterilization<br>Cycle Failure | "Positive" displayed on LCD Display,<br>Audible Alarm…
