(100 days)
Not Found
No
The device description and performance studies focus on the physical properties of the sterilization roll and the chemical indicator, with no mention of AI or ML technology.
No
The device is a sterilization roll used to enclose other medical devices for sterilization and maintain their sterility, not to treat or diagnose patients itself.
No
This device is a Tyvek® roll intended for packaging medical devices for sterilization and maintaining their sterility, not for diagnosing medical conditions. The chemical indicator simply confirms exposure to hydrogen peroxide during sterilization, which is a process indicator, not a diagnostic one.
No
The device is a physical product (a sterilization roll made of Tyvek and plastic film) with a chemical indicator, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose medical devices for sterilization and maintain their sterility. This is a function related to the processing and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description focuses on the physical properties of the roll (materials, sealing) and its function in containing and protecting sterilized devices. It also mentions a chemical indicator for monitoring the sterilization process. None of these aspects relate to in vitro diagnostics.
- 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.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is clearly intended for use in the sterilization process of medical devices, which falls under the category of medical device accessories or sterilization packaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.
The maximum load weight that can be placed in the Tyvek® roll is 3.97 pounds (1.8kg).
The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.
The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow 1 type: Sterilization roll, Flat
Product codes (comma separated list FDA assigned to the subject device)
FRG, JOJ
Device Description
Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices for up to 1 month post sterilization.
The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.
The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in one type as a Flat Sterilization roll. The sterilization roll is made from a Tyvek® sheet and a clear plastic film that are heat sealed together on opposite two sides. After being cut into a suitable length, the product to be sterilized is placed inside and the two open ends are heat sealed. The process indicator printed on the Tyvek® will exhibit a color change after the roll is exposed to hydrogen peroxide (H2O2).
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 workers / 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)
The performance and safety test of subject device was evaluated using the STERLINK™ FPS-15s Plus system, operating in Chamber mode, following the standards listed in the table. Key results for all tests listed (Sterilant Penetration, Shelf-life, Tear resistance, Microbial Barrier Test, CI of sterilization roll validation, Toxicological Properties, Residual sterilant on Tyvek® validation, Material compatibility test) were "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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 22, 2021
Consultant CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401
Re: K212198
Trade/Device Name: Tyvek® Roll with CI for STERLINK™ Sterilizer Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: September 20, 2021 Received: September 21, 2021
Dear Candace Cederman:
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. 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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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).
Sincerely,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212198
Device Name Tyvek® Roll with CI for STERLINK™ Sterilizer
Indications for Use (Describe)
Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.
The maximum load weight that can be placed in the Tyvek® roll is 3.97 pounds (1.8kg).
The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.
The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow 1 type: · Sterilization roll, Flat
| 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
1. General Information
| Applicant/Submitter: | Plasmapp Co., Ltd.
BVC-111, 125, Gwahak-ro,
Yuseong-gu, Daejeon, 34141,
Rep. of Korea (South Korea)
Tel: +82 (0)42 716 2115 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Candace Cederman |
| Address: | CardioMed Device Consultants LLC
1783 Forest Drive
Suite 254
Annapolis, MD 21401
Tel: +1 410 674 2060 |
| Preparation Date: | October 12, 2021 |
2. Device Name and Code
| Device Trade Name: | Tyvek® Roll with CI for STERLINK™ Sterilizer |
|---|---|
| Common Name: | Tyvek® Roll for VH2O2 Sterilizer |
| Classification Name: | 1) Sterilization Wrap |
- Sterilization Process Indicator |
| Product Code: | 1) FRG - JOJ |
| Regulation Number: | 1) 21 CFR 880.6850 - 21 CFR 880.2800 |
| Classification: | Class II |
| Review Panel: | General Hospital |
4
3. Indications / Intended Use
Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.
The maximum load weight that can be placed in the Tyvek® roll is 3.97 pounds (1.8kg).
The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.
The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow 1 type:
- . Sterilization roll, Flat
4. Device Description
Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices for up to 1 month post sterilization.
The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.
The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in one type as a Flat Sterilization roll. The sterilization roll is made from a Tyvek® sheet and a clear plastic film that are heat sealed together on opposite two sides. After being cut into a suitable length, the product to be sterilized is placed inside and the two open ends are heat sealed. The process indicator printed on the Tyvek® will exhibit a color change after the roll is exposed to hydrogen peroxide (H2O2).
5. Technical Characteristics in Comparison to Predicate Devices
The proposed subject device uses identical technology as the cited predicate devices and has the same intended uses. Based upon the overall performance characteristics for Tyvek® Roll with CI for STERLINK™ Sterilizer, Plasmapp Co., Ltd. believes there are no significant differences in
5
usage of its underlying technological principles between Tyvek® Roll with CI for STERLINK™ Sterilizer and the predicate device.
A summary of the technical characteristics of the subject device and predicate device can be found in the table below.
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Sponsor | Plasmapp Co., Ltd. | Sigma Medical Supplies Corp. |
| Manufacturer | Sigma Medical Supplies Corp. | Same |
| Device Name | Tyvek® Roll with CI for STERLINK™ Sterilizer | Sterilization Pouch/Roll Made with Tyvek® |
| 510(k) Number | K212198 | K180672 |
| Device Classification Name | 1) Sterilization Wrap |
- Sterilization Process Indicator | Same |
| Classification Product Code | 1) FRG - JOJ | Same |
| Regulation Number | 1) 21 CFR 880.6850 - 21 CFR 880.2800 | Same |
| Intended Use | Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.
The maximum load weight that can be placed in the Tyvek® roll is 3.97lbs (1.8kg).
The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.
The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow 1 type:
• Sterilization roll, Flat | Sterilization Pouch/Roll Made with Tyvek are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.
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 blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® 100S Sterilizer.
The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:
• Self-sealing sterilization pouches
• Sterilization pouches, Flat
• Sterilization pouches, Gusseted
• Sterilization rolls, Flat
• Sterilization rolls, Gusseted |
| Pouch Types | The subject device includes a subset of the predicate device types:
Sterilization roll, Flat | Self-sealing sterilization pouches
Sterilization pouches, Flat
Sterilization pouches, Gusseted
Sterilization rolls, Flat
Sterilization rolls, Gusseted |
Summary of Subject and Predicate Device Technical Characteristics
6
| Subject Device | Predicate Device | |||
|---|---|---|---|---|
| Sterilization Pouches, Flat | ||||
| Model | Dimensions | |||
| TYFP075200 | 75 mm × 200 mm | |||
| TYFP075300 | 75 mm × 300 mm | |||
| TYFP100200 | 100 mm × 200 mm | |||
| TYFP100300 | 100 mm × 300 mm | |||
| TYFP150255 | 150 mm × 255 mm | |||
| TYFP150300 | 150 mm × 300 mm | |||
| TYFP190330 | 190 mm × 330 mm | |||
| TYFP200400 | 200 mm × 400 mm | |||
| TYFP250450 | 250 mm × 450 mm | |||
| TYFP300500 | 300 mm × 500 mm | |||
| Sterilization Rolls, Flat | ||||
| Model | Dimensions | |||
| TYFR050070 | 50 mm × 70 M | |||
| TYFR022f | 50.8 mm × 61 M | |||
| TYFR075070 | 75 mm × 70 M | |||
| TYFR100070 | 100 mm × 70 M | |||
| TYFR042f | 101.6 mm × 61 M | |||
| Device models | ||||
| (Configurations | ||||
| /Dimensions) | TYFR150070 | 150 mm × 70 M | ||
| Sterilization Roll, Flat | TYFR062f | 152.4 mm × 61 M | ||
| Model | Dimensions | TYFR200070 | 200 mm × 70 M | |
| FR400100 | 400 mm × 100 M | TYFR082f | 203.2 mm × 61 M | |
| TYFR250070 | 250 mm × 70 M | |||
| TYFR102f | 254 mm × 61 M | |||
| TYFR300070 | 300 mm × 70 M | |||
| TYFR350070 | 350 mm × 70 M | |||
| TYFR400070 | 400 mm × 70 M | |||
| TYFR450070 | 450 mm × 70 M | |||
| TYFR500070 | 500 mm × 70 M | |||
| TYFR050100 | 50 mm × 100 M | |||
| TYFR075100 | 75 mm × 100 M | |||
| TYFR100100 | 100 mm × 100 M | |||
| TYFR150100 | 150 mm × 100 M | |||
| TYFR200100 | 200 mm × 100 M | |||
| TYFR250100 | 250 mm × 100 M | |||
| TYFR300100 | 300 mm × 100 M | |||
| TYFR350100 | 350 mm × 100 M | |||
| TYFR400100 | 400 mm × 100 M | |||
| TYFR450100 | 450 mm × 100 M | |||
| TYFR500100 | 500 mm × 100 M | |||
| TYFR050200 | 50 mm × 200 M | |||
| TYFR075200 | 75 mm × 200 M | |||
| TYFR100200 | 100 mm × 200 M | |||
| TYFR150200 | 150 mm × 200 M | |||
| TYFR200200 | 200 mm × 200 M | |||
| TYFR250200 | 250 mm × 200 M | |||
| TYFR300200 | 300 mm × 200 M | |||
| TYFR350200 | 350 mm × 200 M | |||
| TYFR400200 | 400 mm × 200 M |
7
| Subject Device | Predicate Device | |
|---|---|---|
| Material Composition | Tyvek®, PET, PE, Water, CH3COOH, | |
| Alcohol, n-Heptane adhesive, Hydrogen | ||
| peroxide vapor Process Indicator Print Ink | Same | |
| Sterilization Cycle | STERLINK™ FPS-15s Plus - Chamber mode | |
| (overall cycle: 36 minutes) | STERRAD® 100S sterilization cycles: | |
| 54-minute Short cycle for most surgical instruments 72-minute Long cycle for flexible endoscopes and instruments with | ||
| longer lumen | ||
| Design Feature | Sterilization roll, Flat: This roll is made | |
| from a Tyvek® and plastic film that are heat | ||
| sealed on opposite two sides. It will be cut | ||
| into the suitable length and the opened sides | ||
| will be heat-sealed. The indicators printed on | ||
| the Tyvek® are the same with the self-sealing | ||
| sterilization roll. | Same | |
| Chemical Indicator | ||
| Device Design | The color of the Chemical Indicator changes | |
| from red to blue (or lighter) when exposed to | ||
| hydrogen peroxide. | Same |
6. Summary of Non-Clinical Testing
The Tyvek® Roll with CI for STERLINK™ Sterilizer has the identical intended use and indication for use as the predicate devices. Testing of the roll material was previously conducted on the predicate K180672. The identical materials are used in the Tyvek® Roll with CI for STERLINK™ Sterilizer. The size of the subject device is within the range of sizes available for the predicate device.
The performance and safety test of subject device was evaluated using the STERLINK™ FPS-15s Plus system, operating in Chamber mode, following the standards listed in the table below.
| Performance Testing | Standard | Result | |
|---|---|---|---|
| Sterilant | |||
| Penetration | Sterilization efficacy test | ISO 14937 | Pass |
| CI of sterilization roll validation | ANSI/AAMI/ISO 11140-1 | Pass | |
| Shelf-life | Internal pressurization test | ASTM F1980-16 | |
| ASTM F1140/F1140M-13 | Pass | ||
| Visual inspection test | ASTM F1980-16 | ||
| ASTM F1886/F1886M-16 | Pass | ||
| Dye penetration test | ASTM F1980-16 | ||
| ASTM F1929-15 | Pass | ||
| Tensile strength of Tyvek® | ASTM F1980-16 | ||
| ASTM D5035-11 | Pass | ||
| Tensile strength of plastic film | ASTM F1980-16 | ||
| ASTM D882 | Pass | ||
| Seal strength | ASTM F1980-16 | ||
| ASTM F88 | Pass |
8
| Tyvek® Roll with CI for STERLINK™ Sterilize |
|---|
| 510(k) Summary - K212198 |
| Performance Testing | Standard | Result |
|---|---|---|
| Tear resistance | ASTM F1980-16 | |
| ASTM D1922-20 | Pass | |
| Microbial Barrier Test | ASTM F1980-16 | |
| DIN 58953-6 | Pass | |
| CI of sterilization roll validation | ANSI/AAMI/ISO 11140-1 | Pass |
| Toxicological Properties | ||
| (Biocompatibility Tests) | ISO 10993-5 | Pass - Test article is non- |
| cytotoxic after the sterilization. | ||
| Residual sterilant on Tyvek® validation | Internal test standard | Pass |
| Material compatibility test | ASTM D638 | |
| ASTM E8/E8M-ae1 | ||
| ASTM D790 | ||
| ASTM E290-14 | ||
| ASTM D256 | ||
| ASTM E23-18 | ||
| ASTM E1164 | ||
| ASTM E313 | ||
| ASTM D3985 | ||
| ASTM F1249 | ||
| Internal test standard | Pass |
7. Conclusions
The conclusions drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission K212198, Tyvek® Roll with CI for STERLINK™ Sterilizer, is as safe, as effective, and performs as well or better than the legally marketed predicate device cleared under K180672.