(222 days)
Not Found
No
The document describes a physical pouch with a chemical indicator that changes color based on exposure to a sterilant. There is no mention of any computational or data-driven processes that would involve AI or ML. The change in color is a direct chemical reaction, not an algorithmic interpretation.
No
This device is a packaging and sterilization indicator, not a therapeutic device. Its purpose is to enclose medical devices for sterilization and indicate exposure to sterilant, as well as maintain sterility of the enclosed device. It does not provide any therapy or treatment directly to a patient.
No
The device is a chemical indicator that shows exposure to a sterilant, not a diagnostic device used to detect or assess a medical condition. It's used to verify a sterilization process, not for medical diagnosis.
No
The device is a physical product (pouches and rolls) with a chemical indicator printed on it, not a software program.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to enclose medical devices for terminal sterilization and to indicate exposure to sterilant. This is a function related to the sterilization process of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description focuses on the physical construction of the pouch/roll and the chemical indicator's function in showing exposure to hydrogen peroxide vapor. It does not mention any interaction with biological samples or diagnostic procedures.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases
- Using reagents or assays for biological analysis
The device is clearly intended for use in the sterilization of medical devices, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to enclose medical devices that are to be terminally sterilized in the STERRAD Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll is intended to maintain sterility of the enclosed device until used.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2014 [Type I]) that changes from red to the color indicated on the comparator bar included on the shelf pack (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD Sterilization Systems.
Product codes (comma separated list FDA assigned to the subject device)
KCT, JOJ
Device Description
The modified Tyvek Pouch/Roll with STERRAD Chemical Indicator is constructed from Tyvek plastic films, with the STERRAD Chemical Indicator printed onto the Tyvek film. The self-seal pouch permits sealing of the pouch without need of heat-sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD Sterilization Systems.
The modified Tyvek Pouch/Roll with STERRAD Chemical Indicator is intended to enclose medical devices to be terminally sterilized in the STERRAD Sterilization Systems in a single or double pouch configuration. The medical devices are inserted into the pouch/roll, sealed, and then sterilized in the STERRAD Sterilization System.
The only difference between the modified device and the predicate device, is the increased post-processing shelf-life to 12 months.
The STERRAD Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. STERRAD Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to the color indicated by the comparator bar included on the shelf pack (or lighter) when 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification testing was conducted in support of the extended post-processing shelf-life to the Tyvek Pouch/Roll with STERRAD Chemical Indicator that is the subject of this submission; all testing yielded passing results.
Maintenance of Package Integrity: 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with STERRAD Chemical Indicator Post Processing using the STERRAD 100S Sterilization System - Pass
Maintenance of Package Integrity: 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with STERRAD Chemical Indicator Post Processing in the STERRAD 100S Sterilization System using LONG Cycle - Pass
Maintenance of Package Integrity: 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with STERRAD Chemical Indicator Post Processing in the STERRAD NX Sterilization System using ADVANCED Cycle - Pass
Maintenance of Package Integrity: 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with STERRAD Chemical Indicator Post Processing in the STERRAD NX Sterilization System using STANDARD Cycle - Pass
Maintenance of Package Integrity: 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with STERRAD Chemical Indicator Post Processing in the STERRAD 100NX Sterilization System using STANDARD Cycle - Pass
Maintenance of Package Integrity: 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with STERRAD Chemical Indicator Post Processing in the STERRAD 100NX Sterilization System using EXPRESS Cycle - Pass
Maintenance of Package Integrity: 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with STERRAD Chemical Indicator Post Processing in the STERRAD 100NX Sterilization System using DUO Cycle - Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 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 three human profiles facing to the right, with flowing lines representing hair or a stream.
July 31, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Advanced Sterilization Products Ms. Laurie Cartwright Associate Director, Regulatory Affairs 33 Technology Drive Irvine. CA 92618
Re: K163598
Trade/Device Name: Tyvek® Pouch/Roll with STERRAD® Chemical Indicator Regulation Number: 21 CFR 880.6850 /21 CFR 880.2800 Regulation Name: Sterilization Wrap/Sterilization Process Indicator Regulatory Class: Class II Product Code: KCT, JOJ Dated: July 05, 2017 Received: July 07, 2017
Dear Laurie Cartwright:
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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark S. Fellman -S
for
Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163598
Device Name
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
Indications for Use (Describe)
Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to enclose medical devices that are to be terminally sterilized in the STERRAD Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll is intended to maintain sterility of the enclosed device until used.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2014 [Type I]) that changes from red to the color indicated on the comparator bar included on the shelf pack (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD Sterilization Systems.
The pouches and rolls can be used in the STERRAD Sterilization Systems and Cycles shown in Table 1.
| Table 1- Indications for Use | ||||
|---|---|---|---|---|
| STERRAD® / Cycle | Single-channel stainless | |||
| steel lumens | Other lumens | Load requirements | ||
| STERRAD® 100S | ≥1 mm ID x ≤125 mm long | |||
| ≥2 mm ID x ≤250 mm long | ||||
| ≥3 mm ID x ≤400 mm long | Metal and nonmetal | |||
| ≥6 mm ID x ≤310 mm | ||||
| long | ≤10 lumens per load | |||
| STERRAD NX® | ||||
| with or without | ||||
| ALLClear™ Technology | STANDARD | ≥1 mm ID x ≤150 mm long | ||
| ≥2 mm ID x ≤400 mm long | N/A | ≤10 lumens per load ≤10.7 | ||
| lbs | ||||
| ADVANCED | ≥1 mm ID x ≤500 mm long | N/A | ≤10 lumens per load ≤10.7 | |
| lbs | ||||
| STERRAD® 100NX | ||||
| with or without | ||||
| ALLClear™ Technology | STANDARD | ≥0.7 mm ID x ≤500 mm long | N/A | ≤10 lumens per load ≤21.4 |
| lbs | ||||
| EXPRESS | N/A | N/A | ≤10.7 lbs on bottom shelf | |
| only | ||||
| DUO | N/A | N/A | Accessory devices (e.g., | |
| cameras and light cords) only | ||||
| 2 cameras maximum |
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)
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3
Image /page/3/Picture/0 description: The image features a logo with a stylized design. The logo consists of a triangle and the letters 'SP' integrated into a single, continuous line. The entire design is enclosed within a rounded, pill-shaped border, and there is a circled 'R' symbol in the upper right corner, indicating a registered trademark. The logo is presented in a light blue color.
510(k) Summary
Advanced Sterilization Products Tyvek® Pouch/Roll with STERRAD® Chemical Indicator with Extended Post-Processing Shelf-Life
General Information
| Submitter Name: | Advanced Sterilization Products
Division of Ethicon, Inc., a Johnson & Johnson company |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Address: | 33 Technology Drive
Irvine, CA 92618 |
| Contact Person: | Laurie Cartwright
Associate Director, Regulatory Affairs
Telephone: (949) 789-3877
Email: lcartwr@its.jnj.com |
| Date Prepared: | July 26, 2017 |
| 510(k) Number: | K163598 |
| Device Name | |
| Proprietary Name: | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator |
| Common Name: | Sterilization Pouch/Roll with Chemical Indicator |
| Classification Name: | Sterilization Wrap/Sterilization Process Indicator |
| Device Class: | Class II |
| Product Code: | KCT
JOJ |
| CFR Section: | 21 CFR 880.6850
21 CFR 880.2800 |
Predicate Device
Tyvek Pouch/Roll with STERRAD Chemical Indicator cleared under K141693.
Device Description
The modified Tyvek Pouch/Roll with STERRAD Chemical Indicator is constructed from Tyvek plastic films, with the STERRAD Chemical Indicator printed onto the Tyvek film. The self-seal pouch permits sealing of the pouch without need of heat-sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD Sterilization Systems.
The modified Tyvek Pouch/Roll with STERRAD Chemical Indicator is intended to enclose medical devices to be terminally sterilized in the STERRAD Sterilization Systems in a single or double pouch configuration. The medical devices are inserted into the pouch/roll, sealed, and then sterilized in the STERRAD Sterilization System.
The only difference between the modified device and the predicate device, is the increased post-processing shelf-life to 12 months.
The STERRAD Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. STERRAD
4
Image /page/4/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and are set against a light blue background. There is a registered trademark symbol in the upper right corner of the logo.
Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to the color indicated by the comparator bar included on the shelf pack (or lighter) when exposed to hydrogen peroxide.
The product codes for all Tyvek Pouches and Rolls with STERRAD Chemical Indicator are shown in the following table:
| Product Type | Product Codes |
|---|---|
| Tyvek Self-Seal Pouches with STERRAD Chemical | |
| Indicator (123XX) | 12320, 12326, 12335, 12332, 12342, 12340, 12348, |
| 12356 | |
| Tyvek Rolls with STERRAD Chemical Indicator | |
| (124XX) | 12407, 12410, 12415, 12420, 12425, 12435, 12442, |
| 12450 | |
| Tyvek Heat-Seal Pouches with STERRAD | |
| Chemical Indicator (125XX) | 12521, 12526, 12532, 12541, 12548, 12543*, 12544*, |
| 12557*, 12558*, 12559*, 12560* |
- Indicates Product Codes exclusively for markets outside the USA.
Intended Use/Indications for Use
The intended use of the Tyvek Pouch/Roll with STERRAD Chemical Indicator, as described in the 21 CFR 880.6850/21 CFR 880.2800, has not changed as a result of the proposed modification. The Tyvek Pouch/Roll with STERRAD Chemical Indicator (predicate and modified device) is intended to enclose a medical device that is to be sterilized in the STERRAD Sterilization System, and to indicate that the pouch/roll has been exposed to hydrogen peroxide during the sterilization process.
The modified device indication for use is provided below:
Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll is intended to maintain sterility of the enclosed(s) device until used.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2014 [Type I]) that changes from red to the color indicated on the comparator bar included on the shelf pack (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD Sterilization Systems.
The pouches and rolls can be used in the STERRAD Sterilization Systems and Cycles shown in Table 1.
| STERRAD® / Cycle | Single-channel stainless steel lumens | Other lumens | Load requirements | |
|---|---|---|---|---|
| STERRAD® 100S | ≥1 mm ID x ≤125 mm long | |||
| ≥2 mm ID x ≤250 mm long | ||||
| ≥3 mm ID x ≤400 mm long | Metal and nonmetal | |||
| ≥6 mm ID x | ||||
| ≤310 mm long | ≤10 lumens per load | |||
| STERRAD NX® with or | ||||
| without ALLClear™ | ||||
| Technology | STANDARD | ≥1 mm ID x ≤150 mm long | ||
| ≥2 mm ID x ≤400 mm long | N/A | ≤10 lumens per load | ||
| ≤10.7 lbs | ||||
| ADVANCED | ≥1 mm ID x ≤500 mm long | N/A | ≤10 lumens per load | |
| ≤10.7 lbs | ||||
| STERRAD® 100NX | ||||
| with or without | ||||
| ALLClear™ Technology | STANDARD | ≥0.7 mm ID x ≤500 mm long | N/A | ≤10 lumens per load |
| ≤21.4 lbs | ||||
| EXPRESS | N/A | N/A | ≤10.7 lbs on bottom | |
| shelf only | ||||
| DUO | N/A | N/A | Accessory devices (e.g., | |
| cameras and light cords). | ||||
| only 2 cameras | ||||
| maximum |
Table 1- Indications for Use
5
Image /page/5/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and outlined in a light blue color. The logo is enclosed in a rounded rectangle, also in light blue. There is a small registered trademark symbol in the upper right corner of the logo.
Non-Clinical Data
Verification testing was conducted in support of the extended post-processing shelf-life to the Tyvek Pouch/Roll with STERRAD Chemical Indicator that is the subject of this submission; all testing yielded passing results. This testing is summarized in the following table.
| Verification
Testing | Description | Results
(Pass/Fail) |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Maintenance of
Package
Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with
STERRAD Chemical Indicator Post Processing using the
STERRAD 100S Sterilization System | Pass |
| Maintenance of
Package
Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with
STERRAD Chemical Indicator Post Processing in the STERRAD
100S Sterilization System using LONG Cycle | Pass |
| Maintenance of
Package
Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with
STERRAD Chemical Indicator Post Processing in the STERRAD
NX Sterilization System using ADVANCED Cycle | Pass |
| Maintenance of
Package
Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with
STERRAD Chemical Indicator Post Processing in the STERRAD
NX Sterilization System using STANDARD Cycle | Pass |
| Maintenance of
Package
Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with
STERRAD Chemical Indicator Post Processing in the STERRAD
100NX Sterilization System using STANDARD Cycle | Pass |
| Maintenance of
Package
Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with
STERRAD Chemical Indicator Post Processing in the STERRAD
100NX Sterilization System using EXPRESS Cycle | Pass |
| Maintenance of
Package
Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with
STERRAD Chemical Indicator Post Processing in the STERRAD
100NX Sterilization System using DUO Cycle | Pass |
Summary of Performance Testing
Clinical Data
No clinical data was submitted in support of this Premarket Notification.
Summary
The Tyvek Pouch/Roll with STERRAD Chemical Indicator with Extended Post-Processing Shelf-Life and its predicate device, the Tyvek Pouch/Roll with STERRAD Chemical Indicator cleared under K141693, have the same intended use, technological characteristics, design, materials, and principles of operation. Results of maintenance of package integrity verification studies demonstrated that after completion of the sterilization process, the modified device maintains sterility of enclosed medical device(s) for a period of 12 months compared to period of 30 days for the predicate device. Furthermore, the modified device indication for use statement has been updated for clarity (including moving of the post processing shelflife dating to the description section of the Instruction for Use). Refer to the following tables for comparisons between the modified and the predicate device characteristics.
6
Image /page/6/Picture/0 description: The image shows a logo with the letters "ASP" in white against a light blue background. The "A" is represented by a triangle, and the "S" and "P" are stylized and connected. A small registered trademark symbol is visible in the upper right corner of the logo.
| | Predict Tyvek® Pouch/Roll with | Modified Device: Tyvek® Pouch/Roll with STERRAD®
Chemical Indicator with Extended Post-Processing Shelf-Life |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | STERRAD® Chemical Indicator (K141693) | (K163598) |
| Intended Use | The Tyvek Pouch/Roll with STERRAD Chemical Indicator is
intended to enclose a medical device that is to be sterilized in
the STERRAD Sterilization System, and to indicate that the
pouch/roll has been exposed to hydrogen peroxide during the
sterilization process. | Same |
| Indications for
Use | Tyvek® Pouches and Rolls with STERRAD® Chemical
Indicator are intended to be used to enclose medical devices
that are to be terminally sterilized in the STERRAD
Sterilization Systems and Cycles, in a single or double pouch
configuration, and to indicate, by color change, that the pouch
has been exposed to sterilant. After completion of the
sterilization process, the pouch/roll maintains sterility until
the pouch/roll is used; in the United States, this is for a period
of 30 days.
The STERRAD Sterilization Systems and Cycles that can be
used are shown in Table 1. The product codes for all Tyvek
Pouches and Rolls with STERRAD Chemical Indicator are
listed in Table 2.
The pouches and rolls are printed with a chemical indicator
bar which is a process indicator (ISO 11140-1:2005) that
changes from red to yellow (or lighter) when exposed to
hydrogen peroxide vapor during processing in the STERRAD
Sterilization Systems. | Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator
are intended to be used to enclose medical devices that are to be
terminally sterilized in the STERRAD Sterilization Systems and
Cycles, in a single or double pouch configuration, and to indicate,
by color change, that the pouch has been exposed to sterilant.
After completion of the sterilization process, the pouch/roll is
intended to maintain sterility of the enclosed device(s) until used.
The pouches and rolls are printed with a chemical indicator bar
which is a process indicator (ISO 11140-1:2014 [Type I]) that
changes from red to the color indicated on the comparator bar
included on the shelf pack (or lighter) when exposed to hydrogen
peroxide vapor during processing in the STERRAD Sterilization
Systems.
The pouches and rolls can be used in the STERRAD Sterilization
Systems and Cycles shown in Table 1. |
Comparison of Device Characteristics
7
Image /page/7/Picture/0 description: The image is a logo for ASP. The logo is a rounded rectangle with the letters "ASP" in white inside. The "A" is a triangle, and the "P" is a backwards "P". There is a registered trademark symbol in the upper right corner of the logo.
| Predict Tyvek® Pouch/Roll with STERRAD® Chemical Indicator (K141693) | Modified Device: Tyvek® Pouch/Roll with STERRAD® Chemical Indicator with Extended Post-Processing Shelf-Life (K163598) | ||||
|---|---|---|---|---|---|
| STERRAD® / Cycle | Single-channel stainless steel lumens | Other lumens | |||
| Load requirements | STERRAD® / Cycle | Single-channel stainless steel lumens | Other lumens | ||
| Load requirements | |||||
| STERRAD® 100S | ≥1 mm ID x ≤125 mm long | ||||
| ≥2 mm ID x ≤250 mm long | |||||
| ≥3 mm ID x ≤400 mm long | Metal and nonmetal | ||||
| ≥6 mm ID x ≤310 mm long | |||||
| ≤10 lumens per load | STERRAD® 100S | ≥1 mm ID x ≤125 mm long | |||
| ≥2 mm ID x ≤250 mm long | |||||
| ≥3 mm ID x ≤400 mm long | Metal and nonmetal | ||||
| ≥6 mm ID x ≤310 mm long | |||||
| ≤10 lumens per load | |||||
| STERRAD® 50 | ≥1 mm ID x ≤125 mm long | ||||
| ≥2 mm ID x ≤250 mm long | |||||
| ≥3 mm ID x ≤400 mm long | Metal and nonmetal | ||||
| ≥6 mm ID x ≤310 mm long | |||||
| ≤10 lumens per load | STERRAD NX® with or without ALLClear™ Technology | STANDARD | |||
| ≥1 mm ID x ≤150 mm long | |||||
| ≥2 mm ID x ≤400 mm long | |||||
| ADVANCED | |||||
| ≥1 mm ID x ≤500 mm long | N/A | ||||
| ≤10 lumens per load | |||||
| ≤10.7 lbs | |||||
| N/A | |||||
| ≤10 lumens per load | |||||
| ≤10.7 lbs | |||||
| STERRAD® 200 | ≥1 mm ID x ≤125 mm long | ||||
| ≥2 mm ID x ≤250 mm long | |||||
| ≥3 mm ID x ≤400 mm long | Teflon® and polyethylene | ||||
| ≥6 mm ID x ≤310 mm long | |||||
| ≤12 lumens per load | |||||
| ≤36.48 lbs | STERRAD® 100NX with or without ALLClear™ Technology | STANDARD | |||
| ≥0.7 mm ID x ≤500 mm long | |||||
| EXPRESS | |||||
| N/A | |||||
| DUO | |||||
| N/A | N/A | ||||
| ≤10 lumens per load | |||||
| ≤21.4 lbs | |||||
| N/A | |||||
| ≤10.7 lbs on bottom shelf only | |||||
| N/A | |||||
| Accessory devices (e.g., cameras and light cords) only 2 cameras maximum | |||||
| STERRAD NX® | Standard | ||||
| ≥1 mm ID x ≤150 mm long | |||||
| ≥2 mm ID x ≤400 mm long | |||||
| Advanced | |||||
| ≥1 mm ID x ≤500 mm long | N/A | ||||
| ≤10 lumens per load | |||||
| ≤10.7 lbs | |||||
| N/A | |||||
| ≤10 lumens per load | |||||
| ≤10.7 lbs | |||||
| STERRAD 100NX® | Standard | ||||
| ≥0.7 mm ID x ≤500 mm long | |||||
| EXPRESS | |||||
| N/A | |||||
| DUO | |||||
| N/A | N/A | ||||
| ≤10 lumens per load | |||||
| ≤21.4 lbs | |||||
| N/A | |||||
| ≤10.7 lbs on bottom shelf only | |||||
| N/A | |||||
| Accessory devices (e.g., cameras and light cords) only 2 cameras maximum |
8
Image /page/8/Picture/0 description: The image shows a logo with the letters "ASP" in a stylized font. The "A" is represented by a triangle, and the "S" and "P" are connected with a single line. The logo is enclosed in a rounded rectangle with a light blue background. There is a registered trademark symbol in the upper right corner of the logo.
| | Predict Tyvek® Pouch/Roll with
STERRAD® Chemical Indicator (K141693) | Modified Device: Tyvek® Pouch/Roll with STERRAD®
Chemical Indicator with Extended Post-Processing Shelf-Life
(K163598) |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Design Features | Two films which are heat sealed together on three sides for
individual pouches and on two sides for roll form pouches.
A Chemical Indicator (CI) bar is printed onto the Tyvek side
of the pouch. For the self-seal pouch, the CI is printed onto
back surface of the Tyvek. For the heat-seal pouch and roll,
the CI is printed onto the Tyvek, but is encased in the seam of
the pouch between the Tyvek and transparent film. | Same |
| Chemical Indicator | STERRAD indicator ink | Same |
| Chemical Indicator Device Design | The color of the Chemical Indicator changes from red to color indicated by comparator bar (or lighter) when exposed to hydrogen peroxide vapor during the sterilization process in the STERRAD Sterilization Systems. | Same |
| Post-Processing Sterility Shelf-Life | 30 days | 12 months |
9
Image /page/9/Picture/0 description: The image shows a logo with the letters "ASP" in a stylized font. The letters are white and are set against a light blue background. The logo is enclosed in a rounded rectangle shape. There is a registered trademark symbol in the upper right corner of the logo.
| | Predict Tyvek® Pouch/Roll with
STERRAD® Chemical Indicator (K141693) | Modified Device: Tyvek® Pouch/Roll with STERRAD®
Chemical Indicator with Extended Post-Processing Shelf-Life |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Biocompatibility | In vivo testing demonstrated that the pouch samples, after
STERRAD processing, met the acceptance criteria per ISO
10993-11 and 10993-10 and can be safely used. | No new testing. Predicate Device testing applies to modified
device; no change to device materials |
| End Point / Post
Processing Color
Stability | Tyvek Pouches/Rolls, after STERRAD processing,
maintained the endpoint CI color reaction. | No new testing. Predicate Device testing applies to modified
device; no change to device materials |
| Material
Compatibility | Seal strength test, microbial barrier properties, burst test,
and peel open test demonstrated acceptable material
compatibility characteristics of the Tyvek Pouches/Rolls
after STERRAD processing | No new testing. Predicate Device testing applies to modified
device; no change to device materials |
| Sterilant Penetration
Efficacy | The sterilant penetrated through the "double pouch"
configuration under the worst case half-cycle conditions
and the sterility assurance level (SAL) of 10-6 was
demonstrated. | No new testing. Predicate Device testing applies to modified
device; no change to device materials |
| Seal Strength | Seal strength of the processed Tyvek Pouches/Rolls is
maintained at the end of pre-processing shelf life. | No new testing. Predicate Device testing applies to modified
device; no change to device materials |
| Chemical Indicator
(CI) Functionality | CI functionality of the processed Tyvek Pouches/Rolls is
maintained at the end of pre-processing shelf life. | No new testing. Predicate Device testing applies to modified
device; no change to device materials |
| Maintenance of
Package
Integrity | 30 days sterility maintenance post processing in
STERRAD Sterilizers | 12 months sterility maintenance post processing in STERRAD
Sterilizers |
Comparison of Biocompatibility and Performance Testing
10
Image /page/10/Picture/0 description: The image shows a logo with the letters ASP inside of a rounded rectangle. The letters are white, and the rectangle is a light blue color. There is a registered trademark symbol in the upper right corner of the rectangle.
In conclusion, the intended use, operating principle, performance specification, material and design of the modified device are same as the predicate device and the minor differences between the modified device and its predicate device do not raise any new questions of safety or effectiveness. Thus, the Tyvek Pouch/Roll with STERRAD Chemical Indicator with Extended Post-Processing Shelf-Life is substantially equivalent to the predicate device cleared in K141693.