(148 days)
The Perpak™ Sterilization Tyvek Pouch is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the LOWTEM Crystal 120 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 Perpak™ Sterilization Tyyek Pouch is intended to be used to contain medical devices to be terminally sterilized in the LOWTEM Crystal 120 Sterilization System. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the LOWTEM Crystal 120 Sterilization System. After completion of the sterilization process, the Pouch/Roll maintains sterility of the enclosed medical devices until the seal is opened up to 3 years post sterilization.
The device in question is a Perpak™ Sterilization Tyvek Pouch. The document describes several performance tests that demonstrate the device meets its acceptance criteria.
The following information is presented:
1. A table of acceptance criteria and the reported device performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F 1929; ISO 11607-1 | Dye penetration Test (Seal Integrity Test) | No leaks | Pass |
| ASTM F88/F88M; ISO 11607-1 | Seal Peel Test | > 0.6kg.f | Pass |
| ASTM F 2251 | Thickness Variations | Film: 70 ± 10 µm (0.07 ± 0.01mm) Tyvek: 89~282 µm (0.089 ~ 0.282 mm) | Pass |
| ASTM D 503 | Tensile strength of Tyvek® | Tensile strength: Spec > 117 N Elongation: Spec > 10% | Pass |
| ASTM D882 | Tensile strength of plastic film | 1) Spec > 300 kg.f/cm² 2) Elongation: Spec > 50 % | Pass |
| ASTM F1140 | Burst Strength | > 1kg.f/ cm² | Pass |
| ASTM D1922 | Tear Resistance of Tyvek | MD: Spec > 3,400m N TD: Spec > 2,000mN | Pass |
| ASTM D1922 | Tear Resistance of plastic film | MD: Spec > 260m N TD: Spec > 170mN | Pass |
| ASTM F1608 | Microbial Barrier | Log Reduction Value ≥4, ≥99.99% | Pass |
| Sterilant penetration test | Sterilant penetration test of the Perpak Sterilization Tyvek Pouch, Roll using the half-cycle validation of the LOWTEM Crystal 120 Sterilizer | All Negative | Pass |
| Microbial Barrier, Packaging Integrity | Microbial Barrier, Packaging Integrity performance of the Perpak Sterilization Tyvek Pouch, Roll | All processed Cycle tapes, CI strips and SCBI exhibited complete color change and all processed SCBIs were negative for growth. | Pass |
| Sterility test | Sterility test for medical devices packaged with KM Perpak pouch-LOWTEM | Medical devices packaged in KM Perpak TM sterilization pouches after LOWTEM Crystal 120 sterilization cycle have been verified to maintain the sterility (up to 3 years post sterilization, as per indications for use). | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the exact sample sizes used for each test. However, it indicates tests were conducted on "unaged and aged (3 years accelerated aging) devices, before and after sterilization". The data provenance is not specified, but the applicant, KM Corp., is based in the Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are laboratory-based physical and microbiological tests with objective criteria, rather than subjective assessments by human experts.
4. Adjudication method for the test set:
Not applicable, as the tests are objective and based on established industry standards and predefined acceptance criteria.
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:
Not applicable. This device is a sterilization pouch and not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical product, not an algorithm. The performance tests are for the physical integrity and function of the pouch.
7. The type of ground truth used:
The ground truth for these tests is based on established industry standards (e.g., ASTM, ISO standards) and predefined scientific/engineering criteria for physical properties (e.g., tensile strength, burst strength, thickness variation), seal integrity (dye penetration), microbial barrier efficacy (log reduction value), sterilant penetration, and sterility maintenance. For the sterilant penetration and microbial barrier/packaging integrity tests, the ground truth is based on objective indicators like "All Negative" growth or "complete color change" of indicators.
8. The sample size for the training set:
Not applicable. This device is a physical product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 18, 2024
KM Corp. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Kannan Ave. STE 160 Irvine. California 92612
Re: K241123
Trade/Device Name: Perpak™ Sterilization Tyvek Pouch Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: September 2, 2024 Received: September 3, 2024
Dear Priscilla Chung:
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.
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"
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(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 (QS) 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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 mediation-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).
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Sincerely, Christopher K. Dugard -2
Christopher K. Dugard, M.S. Assistant Director THT4C1: Sterility Devices Team DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241123
Device Name Perpak™ Sterilization Tyvek Pouch
Indications for Use (Describe)
The Perpak™ Sterilization Tyvek Pouch is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the LOWTEM Crystal 120 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.
Specifications
| Type | Model name | Dimensions | Max load (Each material) | |
|---|---|---|---|---|
| Metal (g) | Plastic (g) | |||
| SterilizationPouch Flat | AOB00402 | 150mm×600mm | 170 | 360 |
| AOB00164 | 100mm×350mm | 70 | 10 | |
| AOB00163 | 150mm×700mm | 190 | 370 | |
| AOB00162 | 150mm×550mm | 130 | 300 | |
| AOB00161 | 150mm×450mm | 80 | 160 | |
| Sterilization RollFlat | AOA00017 | 400mm×200M | 155 | 355 |
| AOA00016 | 300mm×200M | 140 | 340 | |
| AOA00015 | 250mm×200M | 100 | 330 | |
| AOA00014 | 200mm×200M | 100 | 310 | |
| AOA00013 | 150mm×200M | 80 | 160 | |
| AOA00012 | 100mm×200M | 70 | 10 | |
| AOA00011 | 75mm×200M | 50 | 10 |
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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510(k) Summary
(K241123)
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 09/2/2024
1. Submitter/Applicant
KM Corp. 23-21, Nonggongdanji-gil, Pyeongchang-eup, Pyeongchang-gun, Gangwon-do, Republic of Korea Tel.: +82-31-218-8037 Fax: +82-31-218-8040 Email: info@kmbiz.com
U.S Agent/Contact Person 2.
Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160, Irvine CA 92612 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
Trade Name: Perpak™ Sterilization Tyvek Pouch Common Name: Sterilization Wrap Classification: Class II Classification regulation: 21 CFR 880.6850 Product Code: FRG
4. Predicate Devices:
Sterilization Pouch/Roll Made with Tyvek® by SIGMA Medical Supplies Corp.(K180672)
Device Description: ട്.
The Perpak™ Sterilization Tyyek Pouch is intended to be used to contain medical devices to be terminally sterilized in the LOWTEM Crystal 120 Sterilization System. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the LOWTEM Crystal 120 Sterilization System. After completion of the sterilization process, the Pouch/Roll maintains sterility of the enclosed medical devices until the seal is opened up to 3 years post sterilization.
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Indication for use: 6.
The Perpak™ Sterilization Tyvek Pouch is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the LOWTEM Crystal 120 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.
| Type | Model name | Dimensions | Max load (Each material) | |
|---|---|---|---|---|
| Metal (g) | Plastic (g) | |||
| SterilizationPouch Flat | AOB00402 | 150mm×600mm | 170 | 360 |
| AOB00164 | 100mm×350mm | 70 | 10 | |
| AOB00163 | 150mm×700mm | 190 | 370 | |
| AOB00162 | 150mm×550mm | 130 | 300 | |
| AOB00161 | 150mm×450mm | 80 | 160 | |
| Sterilization RollFlat | AOA00017 | 400mm×200M | 155 | 355 |
| AOA00016 | 300mm×200M | 140 | 340 | |
| AOA00015 | 250mm×200M | 100 | 330 | |
| AOA00014 | 200mm×200M | 100 | 310 | |
| AOA00013 | 150mm×200M | 80 | 160 | |
| AOA00012 | 100mm×200M | 70 | 10 | |
| AOA00011 | 75mm×200M | 50 | 10 |
Specifications
7. Performance Tests
The following performance and shelf-life tests were performed and the test results passed the pre-set criteria, supporting the substantial equivalence to the predicate devices.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM F 1929;ISO 11607-1 | Dye penetration Test(Seal Integrity Test) | No leaks | Pass |
| ASTM F88/F88M;ISO 11607-1 | Seal Peel Test | > 0.6kg.f | Pass |
| ASTM F 2251 | Thickness Variations | Film : 70 ± 10II $ \mu m $(0.07 ± 0.01mm)Tyvek : 89~282 $ \mu m $(0.089 ~ 0.282 mm) | Pass |
| ASTM D 503 | Tensile strength ofTyvek® | Tensile strength: Spec > 117 NElongation : Spec > 10% | Pass |
| ASTM D882 | Tensile strength of plasticfilm | 1) Spec > 300 kg.f/cm $^2$2) Elongation : Spec > 50 % | Pass |
| ASTM F1140 | Burst Strength | > 1kg.f/ cm $^2$ | Pass |
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| ASTM D1922 | Tear Resistance of Tyvek | MD: Spec > 3,400m NTD: Spec > 2,000mN | Pass |
|---|---|---|---|
| ASTM D1922 | Tear Resistance of plasticfilm | MD: Spec > 260m NTD: Spec > 170mN | Pass |
| ASTM F1608 | Microbial Barrier | Log Reduction Value≥4,≥99.99% | Pass |
| Sterilant penetration test | Sterilant penetration testof the Perpak SterilizationTyvek Pouch. Roll usingthe half-cycle validationof the LOWTEM Crystal120 Sterilizer | All Negative | Pass |
| Microbial Barrier,Packaging Integrity | Microbial Barrier,Packaging Integrityperformance of the PerpakSterilization Tyvek Pouch,Roll | All processed Cycle tapes, CI stripsand SCBI exhibited complete colorchange and all processed SCBIswere negative for growth. | Pass |
| Sterility test | Sterility test for medicaldevices packaged withKM Perpak pouch-LOWTEM | Medical devices packaged in KMPerpak TM sterilization pouchesafter LOWTEM Crystal 120sterilization cycle have been verifiedto maintain the sterility | Pass |
8. Comparison of Subject Device to Predicate Device
Comparison Chart
| Comparisoncriteria | Subject Device | Predicate Device | |
|---|---|---|---|
| Company | KM Corp. | SIGMA Medical Supplies Corp. | |
| Device Name | Perpak™ Sterilization Tyvek Pouch | Sterilization Pouch/Roll Made withTyvek® | |
| Commonname | Sterilization Wrap | Sterilization Wrap | |
| ClassificationRegulation | 21 CFR 880.6850 | 21 CFR 880.6850 | |
| Product Code | FRG | FRG, JOJ | |
| 510(k)Number | K241123 | K180672 | |
| Indication foruse | The Perpak™ Sterilization Tyvek Pouch is intended toprovide health care workers with an effective method toenclose devices intended for sterilization in theLOWTEM Crystal 120 Sterilizer. The device isintended to allow sterilization of enclosed devices andalso to maintain sterility of the enclosed devices untilused up to 3 years post sterilization.Specifications | The Sterilization Pouch/Roll Made withTyvek® are intended to provide healthcare workers with an effective method toenclose devices intended for sterilizationin the STERRAD® 100S Sterilizer. Thedevice is intended to allow sterilizationof enclosed devices and also to maintainsterility of the enclosed devices untilused up to 3 years post sterilization.The pouches and rolls are printed with achemical indicator bar which is a processindicator (ISO 11140-1:2005) thatchanges from red to blue (or lighter) | |
| Type | Model nameDimensionsMax load(Each material)Metal (g)Plastic (g) | ||
| AOB00402150mm×600mm170360 | |||
| AOB00164100mm×350mm7010 |
K241123 510(k) Summary, 3 / 5 page
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| SterilizationPouch FlatSterilizationRoll Flat | AOB00163 | 150mm×700mm | 190 | 370 | when exposed to hydrogen peroxidevapor during processing in theSTERRAD® 100S Sterilizer. | |
|---|---|---|---|---|---|---|
| AOB00162 | 150mm×550mm | 130 | 300 | |||
| AOB00161 | 150mm×450mm | 80 | 160 | |||
| AOA00017 | 400mm×200M | 155 | 355 | |||
| AOA00016 | 300mm×200M | 140 | 340 | |||
| AOA00015 | 250mm×200M | 100 | 330 | |||
| AOA00014 | 200mm×200M | 100 | 310 | |||
| AOA00013 | 150mm×200M | 80 | 160 | |||
| AOA00012 | 100mm×200M | 70 | 10 | |||
| AOA00011 | 75mm×200M | 50 | 10 | |||
| MaterialComposition | Tyvek®, Ethylene Polymer, Polyethene(PE),Polyethylene Terephthalate(PET), Bisphenol A-Epichlorohydrin Resin, Polyester polyol,Toluene diisocyanate, Methanol | Tyvek®, PET, PE, Water, CH3COOH,Alcohol, n-Heptane adhesive, Hydrogenperoxide vapor Process Indicator PrintInk | ||||
| SterilizationCycles | The Crystal 120 sterilizer's Standard cycleThe recommended Hydrogen Peroxide SterilizationCycle parameters are exposure time : 16 minutes(Hydrogen Peroxide 59%, 2.5g is injected for each ofthe 4 sterilization injections), exposure Temperature : 55 ± 5°C, Total cycle time : 53 minutes | STERRAD® 100S CycleThe recommended Gas PlasmaSterilization Cycle parameters areexposure time: 6 minutes (Injectionvolume: 2880µL), exposure Temperature:50°C, Plasma Stage - Delivered power:400 Watt. | ||||
| Configuration/Dimension | Various Size• Sterilization pouch, Flat• Sterilization roll, Flat | Various Size• Self-sealing sterilization pouches• Sterilization pouches, Flat• Sterilization pouches, Gusseted• Sterilization rolls, Flat• Sterilization rolls, Gusseted | ||||
| Tests conducted on unaged and aged (3 years accelerated aging) devices, before and after sterilization. | Tests conducted on unaged and aged (3 years accelerated aging) devices, before and after sterilization. | |||||
| MicrobialBarrierProperties(PackagingIntegrity) | Thickness Variations | ASTM F 2251 | Thickness Variations | |||
| ASTM F 2251 | ||||||
| Pass | ||||||
| Tensile strength of plastic film | *ASTM D822 | Tensile strength of plastic film | ||||
| *ASTM D822 | ||||||
| Pass | ||||||
| Tensile strength of Tyvek® | *ASTM D5035 | Tensile strength of Tyvek® | ||||
| *ASTM D5035 | ||||||
| Pass | ||||||
| Tear Resistance | *ASTM D1922 | Tear Resistance | ||||
| *ASTM D1922 | ||||||
| Pass | ||||||
| Burst Strength | ASTM F1140 | Burst Strength | ||||
| ASTM F1140 | ||||||
| Pass | ||||||
| Seal Peel Test | ASTM F88/F88M; ISO 11607-1 | Seal Peel Test | ||||
| ASTM F88/F88M; ISO 11607-1 | ||||||
| Pass | ||||||
| Dye penetration Test(Seal Integrity Test) | ASTM F1929; ISO 11607-1 | Dye penetration Test(Seal Integrity Test) | ||||
| ASTM F1929; ISO 11607-1 | ||||||
| Pass | ||||||
| Microbial Barrier Test | *ASTM F1608 | Microbial Barrier Test | ||||
| *DIN 58953-6 | ||||||
| Pass | ||||||
| *The test items were performed on materials of theproducts; therefore, there is no specificationrequirements. | *The test items were performed onmaterials of the products; therefore, thereis no specification requirements. | |||||
| SterilantPenetration | • Half-Cycle Efficacy: Showed a 6 log reduction ofGeobacillusstearothermophilus | • Half-Cycle Efficacy: Showed a 6 log reduction ofGeobacillusstearothermophilus• Chemical Indicator (CI) Functionalityand Endpoint: The sterilant penetrated through thepouch configuration and affected theCI color change to the endpoint color |
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Technological Comparison Discussion
The subject device is the same as the predicate device in the intended use, design, and technological characteristics. The difference is that the subject device does not include chemical indicator as the sterilizer which is used with the subject device uses a 510k cleared chemical indicator. Another difference is that the material compositions and we performed various performance tests to support the subject device performance.
9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device in 510(k) submission K241123, the Perpak™ Sterilization Tyvek Pouch, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared in K180672.
§ 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).