(222 days)
Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in pouch plus mode and 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 1 lb (450g) for pouch plus mode and 3.97 bs (1.8kg) for chamber mode.
The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2015) 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 following one type:
· Sterilization roll, Flat
Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used 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 STERLINKTM 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).
This prompt describes a medical device, specifically a "Tyvek® Roll with CI for STERLINK™ Sterilizer," and provides information about its regulatory submission (K223025) and comparison to a predicate device (K212198). The document focuses on regulatory approval based on demonstrating substantial equivalence, primarily through non-clinical testing.
However, the provided text does not describe an AI/ML powered medical device and therefore does not contain information typically associated with acceptance criteria or studies used to prove performance for such devices. The questions in the prompt (sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types) are all relevant to the validation of AI/ML algorithms, not to the physical properties and sterilization efficacy of a sterilization wrap.
Therefore, I cannot directly answer your detailed questions about acceptance criteria and study design as if this were an AI/ML device. The information provided is for a traditional medical device (sterilization wrap with a chemical indicator).
Here's how I can address the request based on the actual content of the document:
The document provides a summary of non-clinical testing performed to demonstrate that the subject device (Tyvek® Roll with CI for STERLINK™ Sterilizer) is substantially equivalent to a predicate device, focusing on its ability to maintain sterility and the performance of its chemical indicator.
Acceptance Criteria and Study for a Traditional Medical Device (Sterilization Wrap):
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" for each test but states "Pass" for all performed tests, indicating that the device met the requirements of the standards cited. The acceptance criteria are implicitly defined by the successful completion of the referenced standards.
| Acceptance Criteria (Implied by Standard) | Reported Device Performance |
|---|---|
| Sterility Maintenance/Integrity: | |
| Sterilant Penetration (efficacy of sterilization) (ISO 14937) | Pass |
| 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 |
| Tear resistance (ASTM F1980-16, ASTM D1922-20) | Pass |
| Microbial Barrier Test (ASTM F1980-16, DIN 58953-6) | Pass |
| Chemical Indicator Performance: | |
| Chemical indicator (CI) of sterilization roll validation (ANSI/AAMI/ISO 11140-1) | Pass |
| Biocompatibility/Safety: | |
| Toxicological Properties (Biocompatibility Tests) (ISO 10993-5) | Pass |
| Residual sterilant on Tyvek® validation (Internal test standard) | Pass |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes for each of the non-clinical tests listed.
- Data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. The tests were performed as part of the regulatory submission by Plasmapp Co., Ltd. (South Korea) and its manufacturer Sigma Medical Supplies Corp.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the non-clinical performance testing of a sterilization wrap. "Ground truth" in the context of material science and sterilization efficacy is established by validated laboratory testing against specified standards, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable as the evaluation involves meeting established engineering and biological standards, not human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable as the device is a physical sterilization wrap, not an AI-assisted diagnostic or decision-support tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical sterilization wrap.
7. The type of ground truth used:
- The "ground truth" for this device's performance is established by validated laboratory testing against recognized international and national standards (e.g., ISO 14937, ANSI/AAMI/ISO 11140-1, ASTM series, DIN 58953-6). For biocompatibility, it's ISO 10993-5. For chemical indicator performance, it involves observable color changes under controlled sterilization conditions as per ISO 11140-1.
8. The sample size for the training set:
- This is not applicable as there is no AI/ML algorithm involved that would require a training set.
9. How the ground truth for the training set was established:
- This is not applicable for the same reason as above.
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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".
May 9, 2023
Plasmapp Co., Ltd. % Candace Cederman Consultant CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401
Re: K223025
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: April 7, 2023 Received: April 10, 2023
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
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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 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, Christopher K. Dugard -2
for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Tyvek® Roll with CI for STERLINK™ Sterilizer
Indications for Use (Describe)
Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in pouch plus mode and 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 1 lb (450g) for pouch plus mode and 3.97 bs (1.8kg) for chamber mode.
The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2015) 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 following one type:
· Sterilization roll, Flat
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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510(k) Summary - K223025
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 LLC1783 Forest DriveSuite 254Annapolis, MD 21401Tel: +1 410 674 2060 |
| Preparation Date: | May 9, 2023 |
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 |
| 2) Sterilization Process Indicator | |
| Product Code: | 1) FRG |
| 2) JOJ | |
| Regulation Number: | 1) 21 CFR 880.6850 |
| 2) 21 CFR 880.2800 | |
| Classification: | Class II |
| Review Panel: | General Hospital |
3. Indications / Intended Use
Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in pouch plus and 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 1 1b (450 g) for pouch plus mode and 3.97 lbs (1.8 kg) for chamber mode.
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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 one type:
- Sterilization roll. Flat .
4. Device Description
Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used 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 STERLINKTM 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 the Predicate Device
The proposed subject device uses identical technology as the cited predicate device and has the same intended uses. Based upon the overall performance characteristics for the sterilization wrap and process indicator used with the pouch plus mode of the STERLINK™ FPS-15s Plus sterilizer, Plasmapp Co., Ltd. believes that no significant differences in usage of its underlying technological principles between subject and predicate devices.
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. | Same |
| Manufacturer | Sigma Medical Supplies Corp. | Same |
| Device Name | Tyvek® Roll with CI for STERLINK™Sterilizer | Same |
| 510(k) Number | - | K212198 |
| Device ClassificationName | 1) Sterilization Wrap2) Sterilization Process Indicator | Same |
| Classification ProductCode | 1) FRG2) JOJ | Same |
| Subject Device | Predicate Device | |
| Regulation Number | 1) 21 CFR 880.68502) 21 CFR 880.2800 | Same |
| Tyvek® Roll with CI for STERLINK™Sterilizer, when used in pouch plus andchamber mode, is intended to provide healthcare workers with an effective method toenclose devices intended for sterilization inthe STERLINK™ sterilizer. The device isintended to allow sterilization of encloseddevices and also to maintain sterility of theenclosed devices until used up to 1 monthpost sterilization. | Tyvek® Roll with CI for STERLINK™Sterilizer, when used in CHAMBER mode,is intended to provide health care workerswith an effective method to enclose devicesintended for sterilization in theSTERLINK™ sterilizer. The device isintended to allow sterilization of encloseddevices and also to maintain sterility of theenclosed devices until used up to 1 monthpost sterilization. | |
| Intended Use | The maximum load weight that can beplaced in the Tyvek® roll is 1 lb (450 g) forpouch plus mode and 3.97 lbs (1.8 kg) forchamber mode. | The maximum load weight that can beplaced in the Tyvek® roll is 3.97lbs (1.8kg). |
| The roll is printed with a chemical indicatorbar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (orlighter) when exposed to hydrogen peroxidevapor during processing in theSTERLINK™ sterilizer. | The roll is printed with a chemical indicatorbar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (orlighter) when exposed to hydrogen peroxidevapor during processing in theSTERLINK™ sterilizer. | |
| The Tyvek® Roll with CI for STERLINK™Sterilizer is offered in the follow one type:• Sterilization roll, Flat | The Tyvek® Roll with CI for STERLINK™Sterilizer is offered in the follow one type:• Sterilization roll, Flat | |
| Pouch Types | The subject device includes a subset of thepredicate device types:Sterilization roll, Flat | Same |
| Device models(Configurations/Dimensions) | Sterilization Roll, Flat | |
| ModelFR400100 | Same | |
| Dimensions400 mm × 100 M | ||
| Material Composition | Tyvek®, PET, PE, Water, CH3COOH,Alcohol, n-Heptane adhesive, Hydrogenperoxide vapor Process Indicator Print Ink | Same |
| Sterilization Cycle | STERLINK™ FPS-15s Plus - Pouch plusmode (overall cycle: 14 minutes) | |
| STERLINK™ FPS-15s Plus - Chambermode (overall cycle: 36 minutes) | STERLINK™ FPS-15s Plus - Chambermode (overall cycle: 36 minutes) | |
| Design Feature | Sterilization roll, Flat: This roll is madefrom a Tyvek® and plastic film that are heatsealed on opposite two sides. It will be cutinto the suitable length and the opened sideswill be heat-sealed. The indicators printed onthe Tyvek® are the same with the self-sealingsterilization roll. | Same |
| Chemical IndicatorDevice Design | The color of the Chemical Indicator changesfrom red to blue (or lighter) when exposed tohydrogen peroxide. | Same |
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Tyvek® Roll with CI for STERLINK™ Sterilizer 510(k) Summary - K223025
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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 device. Testing of the roll material was previously conducted on the predicate K212198. The identical materials are used in the Tyvek® Roll with CI for STERLINK™ Sterilizer.
| Performance Testing | Standard | Result | |
|---|---|---|---|
| SterilantPenetration | Sterilization efficacy test | ISO 14937 | Pass |
| CI of sterilization roll validation | ANSI/AAMI/ISO 11140-1 | Pass | |
| Shelf-life | Internal pressurization test | ASTM F1980-16ASTM F1140/F1140M-13 | Pass |
| Visual inspection test | ASTM F1980-16ASTM F1886/F1886M-16 | Pass | |
| Dye penetration test | ASTM F1980-16ASTM F1929-15 | Pass | |
| Tensile strength of Tyvek® | ASTM F1980-16ASTM D5035-11 | Pass | |
| Tensile strength of plastic film | ASTM F1980-16ASTM D882 | Pass | |
| Seal strength | ASTM F1980-16ASTM F88 | Pass | |
| Tear resistance | ASTM F1980-16ASTM D1922-20 | Pass | |
| Microbial Barrier Test | ASTM F1980-16DIN 58953-6 | Pass | |
| CI of sterilization roll validation | ANSI/AAMI/ISO 11140-1 | Pass | |
| Toxicological Properties(Biocompatibility Tests) | ISO 10993-5 | Pass | |
| Residual sterilant on Tyvek® validation | Internal test standard | Pass |
7. Conclusions
The conclusions drawn from the non-clinical tests demonstrates that the subject device in the 510(k) submission, the 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 K212198.
§ 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).