(108 days)
The Medicom Sterilization Pouch and Reel are intended to provide health care workers with an effective method to enclose devices, and they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
- · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
- · Pre-vacuum steam at 134°C (273°F) for 4 minutes; Drying time of 20 minutes.
- · Ethylene Oxide (EO) with a concentration of 600 mg/L at 50°C (122°F) and 60% to 85% relative humidity for 120 minutes. Single Pouch: Aeration time of 5 days at 25°C (77°F). Double Pouches: Aeration time of 3 days at 25°C (77°F).
Furthermore, there are 3 thicknesses for health care workers to choose from as follows:
- · Pouch of Combination A: Medical grade paper 60g+laminated film 44/m
- Pouch of Combination B: Medical grade paper 60g+laminated film 52um
- · Pouch of Combination C: Medical grade paper 70g+laminated film 52um
The Medicom Sterilization Pouch and Reel which are made with Paper maintains the sterility of the enclosed devices for up to 1 year post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
The medical devices are inserted into the Medicom Sterilization Pouch and Reel, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Reel maintains the sterility of the enclosed medical devices until the seal is opened. And they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO).
The device is intended to allow the sterilization of enclosed devices and maintain sterility for the enclosed devices until used up to 1-year post-steam or EO gas sterilization.
The Self-seal pouch permits the sealing of the pouch without heat-sealing equipment, while the heat-sealed pouches and reels are heat-sealed before processing in the steam/or EO Sterilization.
The chemical indicators printed on the "medical grade paper" will exhibit color change after the pouch is exposed to steam or ethylene oxide gas. The "Medicom Sterilization Pouch and Reel" is printed with dual chemical indicators that the color change from Red/Pink to Cocoa when exposed to Steam, and the color changes from Blue to Golden Yellow /Brown, when exposed to EO gas.
The Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, but not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.
Furthermore, there are 3 thicknesses with dimensions for health care workers to choose from as follows:
- Pouch of Combination A: Medical grade paper 60g+laminated film 44um Dimensions of 880 series: W: 57mm ~ 415mm; L: 127mm
727mm Dimensions of 870 series: W: 89mm ~ 457mm; L: 159mm635mm Dimensions of 95 series: W: 50mm ~ 250mm; L: ~30.5M - Pouch of Combination B: Medical grade paper 60g+laminated film 52um Dimensions of 881 series: W: 57mm ~ 381mm; L: 127mm
797mm Dimensions of 871 series: W: 89mm ~ 457mm; L: 159mm559mm Dimensions of 951 series: W: 50mm ~ 250mm; L: ~200M - · Pouch of Combination C: Medical grade paper 70g+laminated film 52um Dimensions of 882 series: W: 57mm ~ 381mm; L: 127mm
797mm Dimensions of 872 series: W: 89mm ~ 457mm; L: 159mm559mm Dimensions of 952 series: W: 50mm ~ 250mm; L: ~200M
The provided text is a 510(k) summary for the Medicom Sterilization Pouch and Reel. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria as would be done for a novel AI/software medical device.
Therefore, much of the requested information (e.g., sample size for test set, data provenance, expert consensus, MRMC studies, AI effect size, training set details) is not applicable to this type of device submission and is not present in the document.
However, I can extract the acceptance criteria and reported performance for the physical and chemical properties of the Medicom Sterilization Pouch and Reel, as these are the relevant performance metrics for this specific device.
Based on the provided document, here's an analysis:
Device: Medicom Sterilization Pouch and Reel (FRG, JOJ - Sterilization Wrap)
1. Table of acceptance criteria and the reported device performance:
The document provides extensive tables (Table 5-4 and Table 5-5) detailing the tests performed, the standards followed, the acceptance criteria, and the results ("Pass"). I will consolidate and present these.
| Test Completed / Feature | Standard Followed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization Efficacy | |||
| Sterilant Penetration Half-Cycle Efficacy (Steam) | ANSI/AAMI/ISO 17665-1:2006/(R)2013, ANSI/AAMI/ISO TIR 17665-2:2009 (R2016) | Meet the requirement of SAL 10^-6, the test BI (Steam processed): No bacterial growth | Pass |
| Drying Time (Steam) | ANSI/AAMI/ISO 17665-1:2006/(R)2013, ANSI/AAMI/ISO TIR 17665-2:2009 (R2016) | The weight difference before sterilization and after drying shall not exceed 0% | Pass |
| Sterilant Penetration Half-Cycle Efficacy (EO Gas) | AAMI / ANSI / ISO 11135:2014 | Meet the requirement of SAL 10^-6, the test BI (EO processed): No bacterial growth | Pass |
| Aeration (EO Gas) | ISO 10993-7:2008 (R) 2012 | EO ≤ 4mg; ECH ≤ 9mg | Pass |
| Biocompatibility Testing | |||
| Cytotoxicity | ISO 10993-5 :2009 | Grade level ≤ 2 | Pass |
| Sensitization | ISO 10993-10:2021 | Sensitization rate ≤ 8% | Pass |
| Irritation | ISO 10993-23:2021 | Non-irritating: mean PII ≤ 0.4 | Pass |
| Package Integrity / Material Compatibility / Sterility Maintenance | |||
| Tensile Strength of Paper | ISO 1924-2:2008 | Machine direction (MD) ≥ 4.4 kN/m; Cross direction (CD) ≥ 2.2 kN/m | Pass |
| Air Permeance of Paper | ISO 5636-3:2013 | ≥ 3.4 µm/(Pa · s) | Pass |
| Thickness Variations | ASTM F 2251-13(2018) | Medical grade paper ≥ 78µm | Pass |
| Visual Inspection (Seal Integrity) | ASTM F1886/F1886M -16 | No visual defects | Pass |
| Burst Strength | ASTM F1140/F1140M-13 (Reapproved 2020) | Self-seal pouches: ≥ 8.0 in. H2O; Heat Seal pouches: ≥ 8.0 in. H2O; Flat reels: ≥ 18.0 in. H2O | Pass |
| Bubble Leak Test | ASTM F1929-15 | No leaks | Pass |
| Seal Peel Test | ASTM F88/F88M-21 | Post-steam /EO sterilization: ≥ 1.5N/15mm (≥ 0.57 lbf/inch) | Pass |
| Microbial Barrier Test | ASTM F1608-21 | LRV ≥ 1.0 | Pass |
| Accelerated Aging Test (Durability) | ASTM F 1980-21 | 3-Year accelerated aging Incubation: Temp: 55°C± 2°C, Relative humidity 50%± 5%; 1 Year accelerated aging Incubation: Temp: 55°C± 2°C, Relative humidity 50%± 5% (These are conditions, the implicit acceptance is that properties are maintained throughout this period) | Pass |
| Chemical Indicator Efficacy (Type 1 Indicators) | |||
| Steam CI Functionality and Endpoint | AAMI/ANSI/ISO 11140-1:2014 | Color changes from Red/Pink to Cocoa when exposed to SteamUnacceptable: 121°C/2.0 min, 132°C/0.3 min, 134°C/0.3 min, Dry heat 140°C/30 min (Color: Red/Pink)Acceptable: 121°C/10.0 min, 132°C/2.0 min, 134°C/2.0 min (Color: Cocoa) | Pass |
| EO Gas CI Functionality and Endpoint | AAMI/ANSI/ISO 11140-1:2014 | Color changes from Blue to Golden Yellow /Brown when exposed to EO gasUnacceptable: EO gas Treat / 2 min, Absence of EO gas / 90 min (Color: Blue)Acceptable: EO gas Treat /20 min (Color: Golden Yellow /Brown) | Pass |
| CI Shelf Life | AAMI/ANSI/ISO 11140-1:2014 | Remain stable before use based on its shelf life for 3 years. | Pass |
| CI Endpoint Color Stability | AAMI/ANSI/ISO 11140-1:2014 | Maintain the endpoint stability of the color change for 1 year after being in the presence of the sterilant. | Pass |
| Other Properties | |||
| Total Lead (Pb) Content Test | (Standard not explicitly listed, but the test is mentioned) | Not Detected (N.D.) | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes used for each physical, chemical, and biological test. It only states that the "results of the Medicom Sterilization Pouch and Reel validation studies demonstrate that the sterilization pouches perform as intended."
- Data Provenance: Not explicitly stated regarding the origin of the test samples (e.g., country of manufacture). The studies appear to be prospective validation tests conducted by the manufacturer to demonstrate performance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The "ground truth" for this device (sterilization pouches and reels) is established by adherence to recognized international standards (e.g., ISO, ASTM, AAMI) for physical, chemical, and biological performance. These standards define the test methods and acceptance criteria. There is no subjective human interpretation or "expert consensus" on ground truth in the way there would be for an AI diagnostic device evaluating medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like "2+1" are relevant for clinical studies involving human readers and subjective interpretations, especially in AI-assisted diagnosis. For physical product testing conforming to specific standards, the results are typically objectively measured and evaluated against predefined thresholds.
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 reel, not an AI or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not a software algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on objective, measurable criteria defined by recognized international standards (e.g., successful microbial inactivation as per SAL 10^-6, specific tensile strengths, lack of leaks, defined color changes for chemical indicators, biocompatibility profiles). These are established through laboratory testing following validated protocols, not through expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo for 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 text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
February 21, 2025
Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. % Uta Shih Regulatory Affairs Manager Sen Mu Technology Co., LTD. 15F.-2, No.1. Ln. 26, Minquan 1st Rd., Lingya Dist Kaohsiung City, Taiwan 802 Taiwan
Re: K243431
Trade/Device Name: Medicom Sterilization Pouch and Reel Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: November 5, 2024 Received: January 21, 2025
Dear Uta Shih:
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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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 Rule"). 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-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-regulatory
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assistance/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 -5
Christopher K. Dugard, M.S. Division Director 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) K243431
Device Name Medicom Sterilization Pouch and Reel
Indications for Use (Describe)
The Medicom Sterilization Pouch and Reel are intended to provide s with an effective method to enclose devices, and they can use Single Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes. Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. Pre-vacuum steam at 134°C (273°F) for 4 minutes; Drying time of 20 minutes. Ethylene Oxide (EO) with a concentration of 600 mg/L at 50°C (122°F) and 60% to 85% relative humidity for 120 minutes. Single Pouch: Aeration time of 5 days at 25°C (77°F). Double Pouches: Aeration time of 3 days at 25°C (77°F).
Furthermore, there are 3 thicknesses for health care workers to choose from as follows:
Pouch of Combination A: Medical grade paper 60g+laminated film 44um Pouch of Combination B: Medical grade paper 60g+laminated film 52um Pouch of Combination C: Medical grade paper 70g+laminated film 52um
The Medicom Sterilization Pouch and Reel which are made with Paper maintains the sterility of the enclosed devices for up to 1 year post Steam or EO gas sterilization and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the pouch has undergone either a steam or EO sterilization process.
The following table (Table 5-1 to Table 5-3) lists the model numbers of the Medicom Sterilization Pouch and Reel by type, model, dimensions, and max. load (Ibs.):
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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Table 5-1. The model numbers of Medicom Sterilization Pouch and Reel (Medical grade paper 60g+laminated film 44um: Type, Model and Dimension and Max.
| Pouch of Combination A: Medical grade paper 60g+laminated film 44µm | |||
|---|---|---|---|
| Type | Dimension | Model | Max. Load (lb.) |
| Medicom Self-seal Pouch | 57x127 mm | 88015-4 | 0.03 |
| Medicom Self-seal Pouch | 70x254 mm | 88000-4 | 0.32 |
| Medicom Self-seal Pouch | 89x159 mm | 88005-4 | 0.20 |
| Medicom Self-seal Pouch | 89x191 mm | 88001-4 | 0.27 |
| Medicom Self-seal Pouch | 89x254 mm | 88010-4 | 0.44 |
| Medicom Self-seal Pouch | 89x286 mm | 88003-4 | 0.50 |
| Medicom Self-seal Pouch | 83x330 mm | 88004-4 | 0.57 |
| Medicom Self-seal Pouch | 89x617 mm | 88006-4 | 1.23 |
| Medicom Self-seal Pouch | 108x305 mm | 88009-4 | 0.70 |
| Medicom Self-seal Pouch | 133x190 mm | 88011-4 | 0.48 |
| Medicom Self-seal Pouch | 133x279 mm | 88025-4 | 0.79 |
| Medicom Self-seal Pouch | 133x311 mm | 88013-4 | 0.87 |
| Medicom Self-seal Pouch | 133x330 mm | 88014-4 | 0.96 |
| Medicom Self-seal Pouch | 133x413 mm | 88017-4 | 1.20 |
| Medicom Self-seal Pouch | 190x356 mm | 88030-4 | 1.46 |
| Medicom Self-seal Pouch | 191x388 mm | 88022-4 | 1.57 |
| Medicom Self-seal Pouch | 203x356 mm | 88023-4 | 1.55 |
| Medicom Self-seal Pouch | 203x464 mm | 88024-4 | 1.95 |
| Medicom Self-seal Pouch | 229x407 mm | 88028-4 | 1.94 |
| Medicom Self-seal Pouch | 254x381 mm | 88035-4 | 1.99 |
| Medicom Self-seal Pouch | 267x457 mm | 88029-4 | 2.38 |
| Medicom Self-seal Pouch | 305x457 mm | 88040-4 | 2.59 |
| Medicom Self-seal Pouch | 305x515 mm | 88032-4 | 2.76 |
| Medicom Self-seal Pouch | 330x533 mm | 88034-4 | 2.92 |
| Medicom Self-seal Pouch | 415x636 mm | 88038-4 | 2.98 |
| Medicom Self-seal Pouch | 381x727 mm | 88090-4 | 2.90 |
| Medicom Heat Seal Pouch | 89x159 mm | 870010 | 0.27 |
| Medicom Heat seal pouch | 89x254 mm | 870020 | 0.50 |
| Medicom Heat Seal Pouch | 89x584 mm | 870040 | 1.23 |
| Medicom Heat Seal Pouch | 133x279 mm | 870060 | 0.87 |
| Medicom Heat Seal Pouch | 133x381 mm | 870070 | 1.20 |
| Medicom Heat Seal Pouch | 152x279 mm | 870100 | 1.00 |
| Medicom Heat Seal Pouch | 152x406 mm | 870110 | 1.44 |
| Medicom Heat Seal Pouch | 191x356 mm | 870140 | 1.57 |
| Medicom Heat Seal Pouch | 203x432 mm | 870160 | 1.95 |
| Medicom Heat Seal Pouch | 203x635 mm | 870170 | 2.56 |
| Medicom Heat Seal Pouch | 305x483 mm | 870200 | 2.76 |
| Medicom Heat Seal Pouch | 415x603mm | 870210 | 2.98 |
| Medicom Heat seal pouch | 457x559mm | 870220 | 2.96 |
| Medicom Flat Reel | 50mmx30.5M | 9510 | 0.26 |
| Medicom Flat Reel | 75mmx30.5M | 9520 | 0.56 |
| Medicom Flat Reel | 100mmx30.5M | 9530 | 0.84 |
| Medicom Flat Reel | 150mmx30.5M | 9540 | 1.38 |
| Medicom Flat Reel | 200mmx30.5M | 9550 | 1.88 |
| Medicom Flat Reel | 250mm x 30.5M | 9560 | 2.35 |
Load)
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Table 5-2. The model numbers of Medicom Sterilization Pouch and Reel (Medical grade paper 60g+laminated film 52μm: Type, Model and Dimension and Max. Load)
| Pouch of Combination B: Medical grade paper 60g+laminated film 52um | |||
|---|---|---|---|
| Type | Dimension | Model | Max. Load (lb.) |
| Medicom Self-seal Pouch | 57x127 mm | 881010 | 0.03 |
| Medicom Self-seal Pouch | 89x159 mm | 881030 | 0.20 |
| Medicom Self-seal Pouch | 89x254 mm | 881050 | 0.44 |
| Medicom Self-seal Pouch | 89x264 mm | 881060 | 0.44 |
| Medicom Self-seal Pouch | 89x594 mm | 881100 | 1.17 |
| Medicom Self-seal Pouch | 89x695 mm | 881110 | 1.38 |
| Medicom Self-seal Pouch | 133x279 mm | 881140 | 0.79 |
| Medicom Self-seal Pouch | 133x289 mm | 881150 | 0.79 |
| Medicom Self-seal Pouch | 133x340 mm | 881180 | 0.96 |
| Medicom Self-seal Pouch | 127x416 mm | 881200 | 1.14 |
| Medicom Self-seal Pouch | 140x356 mm | 881210 | 1.09 |
| Medicom Self-seal Pouch | 152x746 mm | 881220 | 2.28 |
| Medicom Self-seal Pouch | 190x356 mm | 881230 | 1.46 |
| Medicom Self-seal Pouch | 190x365 mm | 881240 | 1.46 |
| Medicom Self-seal Pouch | 203x441 mm | 881280 | 1.85 |
| Medicom Self-seal Pouch | 203x797 mm | 881290 | 2.83 |
| Medicom Self-seal Pouch | 267x457 mm | 881320 | 2.38 |
| Medicom Self-seal Pouch | 305x406 mm | 881330 | 2.40 |
| Medicom Self-seal Pouch | 305x416 mm | 881340 | 2.40 |
| Medicom Self-seal Pouch | 305x457 mm | 881350 | 2.59 |
| Medicom Self-seal Pouch | 305x492 mm | 881370 | 2.68 |
| Medicom Self-seal Pouch | 350x483 mm | 881390 | 2.84 |
| Medicom Self-seal Pouch | 381x635 mm | 881400 | 3.06 |
| Medicom Self-seal Pouch | 381x727 mm | 881410 | 2.90 |
| Medicom Heat Seal Pouch | 89x159mm | 871010 | 0.27 |
| Medicom Heat Seal Pouch | 89x559 mm | 871030 | 1.17 |
| Medicom Heat Seal Pouch | 102x203 mm | 871050 | 0.45 |
| Medicom Heat Seal Pouch | 127x381 mm | 871080 | 1.14 |
| Medicom Heat Seal Pouch | 152x254 mm | 871090 | 0.91 |
| Medicom Heat Seal Pouch | 152x559 mm | 871120 | 1.90 |
| Medicom Heat Seal Pouch | 190x330 mm | 871130 | 1.46 |
| Medicom Heat Seal Pouch | 203x406 mm | 871150 | 1.85 |
| Medicom Heat Seal Pouch | 305x381 mm | 871180 | 2.40 |
| Medicom Heat Seal Pouch | 305x457 mm | 871190 | 2.68 |
| Medicom Heat Seal Pouch | 457x559 mm | 871220 | 2.96 |
| Medicom Flat Reel | 50mm x 30.5M | 951010 | 0.26 |
| Medicom Flat Reel | 75mm x 30.5M | 951020 | 0.56 |
| Medicom Flat Reel | 75mm x 200M | 951070 | 0.56 |
| Medicom Flat Reel | 100mm x 30.5M | 951030 | 0.84 |
| Medicom Flat Reel | 100mm x 200M | 951080 | 0.84 |
| Medicom Flat Reel | 150mm x 30.5M | 951040 | 1.38 |
| Medicom Flat Reel | 150mm x 200M | 951090 | 1.38 |
| Medicom Flat Reel | 200mm x 30.5M | 951050 | 1.88 |
| Medicom Flat Reel | 200mm x 200M | 951091 | 1.88 |
| Medicom Flat Reel | 250mm x 30.5M | 951060 | 2.35 |
| Medicom Flat Reel | 250mm x 200M | 951092 | 2.35 |
| Pouch of Combination C: Medical grade paper 70g+laminated film 52μm | |||
| Type | Dimension | Model | Max. Load (lb.) |
| Medicom Self-seal Pouch | 57x127mm | 882010 | 0.03 |
| Medicom Self-seal Pouch | 89x159 mm | 882030 | 0.20 |
| Medicom Self-seal Pouch | 89x254 mm | 882050 | 0.44 |
| Medicom Self-seal Pouch | 89x264 mm | 882060 | 0.44 |
| Medicom Self-seal Pouch | 89x594 mm | 882100 | 1.17 |
| Medicom Self-seal Pouch | 89x695 mm | 882110 | 1.38 |
| Medicom Self-seal Pouch | 133x279mm | 882140 | 0.79 |
| Medicom Self-seal Pouch | 133x289 mm | 882150 | 0.79 |
| Medicom Self-seal Pouch | 133x340 mm | 882180 | 0.96 |
| Medicom Self-seal Pouch | 127x416 mm | 882200 | 1.14 |
| Medicom Self-seal Pouch | 140x356 mm | 882210 | 1.09 |
| Medicom Self-seal Pouch | 152x746 mm | 882220 | 2.28 |
| Medicom Self-seal Pouch | 190x356 mm | 882230 | 1.46 |
| Medicom Self-seal Pouch | 190x365 mm | 882240 | 1.46 |
| Medicom Self-seal Pouch | 203x441 mm | 882280 | 1.85 |
| Medicom Self-seal Pouch | 203x797 mm | 882290 | 2.82 |
| Medicom Self-seal Pouch | 267x457mm | 882320 | 2.38 |
| Medicom Self-seal Pouch | 305x406 mm | 882330 | 2.40 |
| Medicom Self-seal Pouch | 305x416mm | 882340 | 2.40 |
| Medicom Self-seal Pouch | 305x457mm | 882350 | 2.59 |
| Medicom Self-seal Pouch | 305x492 mm | 882370 | 2.68 |
| Medicom Self-seal Pouch | 350x483 mm | 882390 | 2.84 |
| Medicom Self-seal Pouch | 381x635 mm | 882400 | 3.06 |
| Medicom Self-seal Pouch | 381x727 mm | 882410 | 2.90 |
| Medicom Heat Seal Pouch | 89x159mm | 872010 | 0.27 |
| Medicom Heat Seal Pouch | 89x559 mm | 872030 | 1.17 |
| Medicom Heat Seal Pouch | 102x203 mm | 872050 | 0.45 |
| Medicom Heat Seal Pouch | 127x381 mm | 872080 | 1.14 |
| Medicom Heat Seal Pouch | 152x254 mm | 872090 | 0.91 |
| Medicom Heat Seal Pouch | 152x559 mm | 872120 | 1.90 |
| Medicom Heat Seal Pouch | 190x330 mm | 872130 | 1.46 |
| Medicom Heat Seal Pouch | 203x406 mm | 872150 | 1.85 |
| Medicom Heat Seal Pouch | 305x381 mm | 872180 | 2.40 |
| Medicom Heat Seal Pouch | 305x457 mm | 872190 | 2.68 |
| Medicom Heat Seal Pouch | 457x559 mm | 872220 | 2.96 |
| Medicom Flat Reel | 50mm x 30.5M | 952010 | 0.26 |
| Medicom Flat Reel | 75mm x 30.5M | 952020 | 0.56 |
| Medicom Flat Reel | 75mm x 200M | 952070 | 0.56 |
| Medicom Flat Reel | 100mm x 30.5M | 952030 | 0.84 |
| Medicom Flat Reel | 100mm x 200M | 952080 | 0.84 |
| Medicom Flat Reel | 150mm x 30.5M | 952040 | 1.38 |
| Medicom Flat Reel | 150mm x 200M | 952090 | 1.38 |
| Medicom Flat Reel | 200mm x 30.5M | 952050 | 1.88 |
| Medicom Flat Reel | 200mm x 200M | 952100 | 1.88 |
| Medicom Flat Reel | 250mm x 30.5M | 952060 | 2.35 |
| Medicom Flat Reel | 250mm x 200M | 952110 | 2.35 |
{7}------------------------------------------------
{8}------------------------------------------------
Table 5-3. The model numbers of Medicom Sterilization Pouch and Reel (Medical grade paper 70g+laminated film 52μm: Type, Model and Dimension and Max. Load)
{9}------------------------------------------------
{10}------------------------------------------------
K243431 - 510 (K) Summary
Submitter's Information
| Name: | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. |
|---|---|
| Address: | No. 11, Sec. 2, Ligong 1st Rd, Wujie Township, YilanCounty 26841, Taiwan |
| EstablishmentRegistration Number: | 3008132392 |
| Contact: | Henry ChuGeneral ManagerTEL: +886-3-990-9100email: hchu@medicom-taiwan.comemail: sales@medicom-taiwan.com |
| Date Prepared: | February 20, 2025 |
Device Name
| Trade Name: | Medicom Sterilization Pouch and Reel |
|---|---|
| Common/usual Name: | Medicom Sterilization Pouch and Reel |
| Device Classification Names: | 1) Wrap, Sterilization.2) Indicator, Physical/Chemical Sterilization Process |
| Panel: | General Hospital |
| Classification Product Code: | 1) FRG |
| Subsequent Product Code: | 2) JOJ |
| Device Classification: | Class II |
| Regulation Number: | 1) 21 CFR 880.68502) 21 CFR 880.2800 |
Predicate Devices
The predicate device [510(k) Notification K153540, cleared August 4, 2016] is the Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators.
{11}------------------------------------------------
Indications for Use
The Medicom Sterilization Pouch and Reel are intended to provide health care workers with an effective method to enclose devices, and they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
- · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
- · Pre-vacuum steam at 134°C (273°F) for 4 minutes; Drying time of 20 minutes.
- · Ethylene Oxide (EO) with a concentration of 600 mg/L at 50°C (122°F) and 60% to 85% relative humidity for 120 minutes. Single Pouch: Aeration time of 5 days at 25°C (77°F). Double Pouches: Aeration time of 3 days at 25°C (77°F).
Furthermore, there are 3 thicknesses for health care workers to choose from as follows:
- · Pouch of Combination A: Medical grade paper 60g+laminated film 44/m
- Pouch of Combination B: Medical grade paper 60g+laminated film 52um
- · Pouch of Combination C: Medical grade paper 70g+laminated film 52um
The Medicom Sterilization Pouch and Reel which are made with Paper maintains the sterility of the enclosed devices for up to 1 year post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
The following table (Table 5-1 to Table 5-3) lists the model numbers of the Medicom Sterilization Pouch and Reel by type, model, dimensions, and max. load (lbs.):
{12}------------------------------------------------
Table 5-1. The model numbers of Medicom Sterilization Pouch and Reel
(Medical grade paper 60g+laminated film 44μm: Type, Model and Dimension and Max.
Load)
| Pouch of Combination A: Medical grade paper 60g+laminated film 44µm | |||
|---|---|---|---|
| Type | Dimension | Model | Max. Load (lb.) |
| Medicom Self-seal Pouch | 57x127 mm | 88015-4 | 0.03 |
| Medicom Self-seal Pouch | 70x254 mm | 88000-4 | 0.32 |
| Medicom Self-seal Pouch | 89x159 mm | 88005-4 | 0.20 |
| Medicom Self-seal Pouch | 89x191 mm | 88001-4 | 0.27 |
| Medicom Self-seal Pouch | 89x254 mm | 88010-4 | 0.44 |
| Medicom Self-seal Pouch | 89x286 mm | 88003-4 | 0.50 |
| Medicom Self-seal Pouch | 83x330 mm | 88004-4 | 0.57 |
| Medicom Self-seal Pouch | 89x617 mm | 88006-4 | 1.23 |
| Medicom Self-seal Pouch | 108x305 mm | 88009-4 | 0.70 |
| Medicom Self-seal Pouch | 133x190 mm | 88011-4 | 0.48 |
| Medicom Self-seal Pouch | 133x279 mm | 88025-4 | 0.79 |
| Medicom Self-seal Pouch | 133x311 mm | 88013-4 | 0.87 |
| Medicom Self-seal Pouch | 133x330 mm | 88014-4 | 0.96 |
| Medicom Self-seal Pouch | 133x413 mm | 88017-4 | 1.20 |
| Medicom Self-seal Pouch | 190x356 mm | 88030-4 | 1.46 |
| Medicom Self-seal Pouch | 191x388 mm | 88022-4 | 1.57 |
| Medicom Self-seal Pouch | 203x356 mm | 88023-4 | 1.55 |
| Medicom Self-seal Pouch | 203x464 mm | 88024-4 | 1.95 |
| Medicom Self-seal Pouch | 229x407 mm | 88028-4 | 1.94 |
| Medicom Self-seal Pouch | 254x381 mm | 88035-4 | 1.99 |
| Medicom Self-seal Pouch | 267x457 mm | 88029-4 | 2.38 |
| K243431 | 510(K) SUMMARY | ||
| Medicom Self-seal Pouch | 305x457 mm | 88040-4 | 2.59 |
| Medicom Self-seal Pouch | 305x515 mm | 88032-4 | 2.76 |
| Medicom Self-seal Pouch | 330x533 mm | 88034-4 | 2.92 |
| Medicom Self-seal Pouch | 415x636 mm | 88038-4 | 2.98 |
| Medicom Self-seal Pouch | 381x727 mm | 88090-4 | 2.90 |
| Medicom Heat Seal Pouch | 89x159 mm | 870010 | 0.27 |
| Medicom Heat seal pouch | 89x254 mm | 870020 | 0.50 |
| Medicom Heat Seal Pouch | 89x584 mm | 870040 | 1.23 |
| Medicom Heat Seal Pouch | 133x279 mm | 870060 | 0.87 |
| Medicom Heat Seal Pouch | 133x381 mm | 870070 | 1.20 |
| Medicom Heat Seal Pouch | 152x279 mm | 870100 | 1.00 |
| Medicom Heat Seal Pouch | 152x406 mm | 870110 | 1.44 |
| Medicom Heat Seal Pouch | 191x356 mm | 870140 | 1.57 |
| Medicom Heat Seal Pouch | 203x432 mm | 870160 | 1.95 |
| Medicom Heat Seal Pouch | 203x635 mm | 870170 | 2.56 |
| Medicom Heat Seal Pouch | 305x483 mm | 870200 | 2.76 |
| Medicom Heat Seal Pouch | 415x603mm | 870210 | 2.98 |
| Medicom Heat seal pouch | 457x559mm | 870220 | 2.96 |
| Medicom Flat Reel | 50mmx30.5M | 9510 | 0.26 |
| Medicom Flat Reel | 75mmx30.5M | 9520 | 0.56 |
| Medicom Flat Reel | 100mmx30.5M | 9530 | 0.84 |
| Medicom Flat Reel | 150mmx30.5M | 9540 | 1.38 |
| Medicom Flat Reel | 200mmx30.5M | 9550 | 1.88 |
| Medicom Flat Reel | 250mm x 30.5M | 9560 | 2.35 |
{13}------------------------------------------------
{14}------------------------------------------------
Table 5-2. The model numbers of Medicom Sterilization Pouch and Reel
(Medical grade paper 60g+laminated film 52μm: Type, Model and Dimension and Max.
Load)
| Pouch of Combination B: Medical grade paper 60g+laminated film 52µm | |||
|---|---|---|---|
| Type | Dimension | Model | Max. Load (lb.) |
| Medicom Self-seal Pouch | 57x127 mm | 881010 | 0.03 |
| Medicom Self-seal Pouch | 89x159 mm | 881030 | 0.20 |
| Medicom Self-seal Pouch | 89x254 mm | 881050 | 0.44 |
| Medicom Self-seal Pouch | 89x264 mm | 881060 | 0.44 |
| Medicom Self-seal Pouch | 89x594 mm | 881100 | 1.17 |
| Medicom Self-seal Pouch | 89x695 mm | 881110 | 1.38 |
| Medicom Self-seal Pouch | 133x279 mm | 881140 | 0.79 |
| Medicom Self-seal Pouch | 133x289 mm | 881150 | 0.79 |
| Medicom Self-seal Pouch | 133x340 mm | 881180 | 0.96 |
| Medicom Self-seal Pouch | 127x416 mm | 881200 | 1.14 |
| Medicom Self-seal Pouch | 140x356 mm | 881210 | 1.09 |
| Medicom Self-seal Pouch | 152x746 mm | 881220 | 2.28 |
| Medicom Self-seal Pouch | 190x356 mm | 881230 | 1.46 |
| Medicom Self-seal Pouch | 190x365 mm | 881240 | 1.46 |
| Medicom Self-seal Pouch | 203x441 mm | 881280 | 1.85 |
| Medicom Self-seal Pouch | 203x797 mm | 881290 | 2.83 |
| Medicom Self-seal Pouch | 267x457 mm | 881320 | 2.38 |
| Medicom Self-seal Pouch | 305x406 mm | 881330 | 2.40 |
| Medicom Self-seal Pouch | 305x416 mm | 881340 | 2.40 |
| Medicom Self-seal Pouch | 305x457 mm | 881350 | 2.59 |
| Medicom Self-seal Pouch | 305x492 mm | 881370 | 2.68 |
| K243431 | 510(K) SUMMARY | ||
| Medicom Self-seal Pouch | 350x483 mm | 881390 | 2.84 |
| Medicom Self-seal Pouch | 381x635 mm | 881400 | 3.06 |
| Medicom Self-seal Pouch | 381x727 mm | 881410 | 2.90 |
| Medicom Heat Seal Pouch | 89x159mm | 871010 | 0.27 |
| Medicom Heat Seal Pouch | 89x559 mm | 871030 | 1.17 |
| Medicom Heat Seal Pouch | 102x203 mm | 871050 | 0.45 |
| Medicom Heat Seal Pouch | 127x381 mm | 871080 | 1.14 |
| Medicom Heat Seal Pouch | 152x254 mm | 871090 | 0.91 |
| Medicom Heat Seal Pouch | 152x559 mm | 871120 | 1.90 |
| Medicom Heat Seal Pouch | 190x330 mm | 871130 | 1.46 |
| Medicom Heat Seal Pouch | 203x406 mm | 871150 | 1.85 |
| Medicom Heat Seal Pouch | 305x381 mm | 871180 | 2.40 |
| Medicom Heat Seal Pouch | 305x457 mm | 871190 | 2.68 |
| Medicom Heat Seal Pouch | 457x559 mm | 871220 | 2.96 |
| Medicom Flat Reel | 50mm x 30.5M | 951010 | 0.26 |
| Medicom Flat Reel | 75mm x 30.5M | 951020 | 0.56 |
| Medicom Flat Reel | 75mm x 200M | 951070 | 0.56 |
| Medicom Flat Reel | 100mm x 30.5M | 951030 | 0.84 |
| Medicom Flat Reel | 100mm x 200M | 951080 | 0.84 |
| Medicom Flat Reel | 150mm x 30.5M | 951040 | 1.38 |
| Medicom Flat Reel | 150mm x 200M | 951090 | 1.38 |
| Medicom Flat Reel | 200mm x 30.5M | 951050 | 1.88 |
| Medicom Flat Reel | 200mm x 200M | 951091 | 1.88 |
| Medicom Flat Reel | 250mm x 30.5M | 951060 | 2.35 |
| Medicom Flat Reel | 250mm x 200M | 951092 | 2.35 |
{15}------------------------------------------------
Medicom sterilization pouch and reel
{16}------------------------------------------------
Table 5-3. The model numbers of Medicom Sterilization Pouch and Reel
(Medical grade paper 70g+laminated film 52μm: Type, Model and Dimension and Max.
Load)
| Pouch of Combination C: Medical grade paper 70g+laminated film 52µm | |||
|---|---|---|---|
| Type | Dimension | Model | Max. Load (lb.) |
| Medicom Self-seal Pouch | 57x127mm | 882010 | 0.03 |
| Medicom Self-seal Pouch | 89x159 mm | 882030 | 0.20 |
| Medicom Self-seal Pouch | 89x254 mm | 882050 | 0.44 |
| Medicom Self-seal Pouch | 89x264 mm | 882060 | 0.44 |
| Medicom Self-seal Pouch | 89x594 mm | 882100 | 1.17 |
| Medicom Self-seal Pouch | 89x695 mm | 882110 | 1.38 |
| Medicom Self-seal Pouch | 133x279mm | 882140 | 0.79 |
| Medicom Self-seal Pouch | 133x289 mm | 882150 | 0.79 |
| Medicom Self-seal Pouch | 133x340 mm | 882180 | 0.96 |
| Medicom Self-seal Pouch | 127x416 mm | 882200 | 1.14 |
| Medicom Self-seal Pouch | 140x356 mm | 882210 | 1.09 |
| Medicom Self-seal Pouch | 152x746 mm | 882220 | 2.28 |
| Medicom Self-seal Pouch | 190x356 mm | 882230 | 1.46 |
| Medicom Self-seal Pouch | 190x365 mm | 882240 | 1.46 |
| Medicom Self-seal Pouch | 203x441 mm | 882280 | 1.85 |
| Medicom Self-seal Pouch | 203x797 mm | 882290 | 2.82 |
| Medicom Self-seal Pouch | 267x457mm | 882320 | 2.38 |
| Medicom Self-seal Pouch | 305x406 mm | 882330 | 2.40 |
| Medicom Self-seal Pouch | 305x416mm | 882340 | 2.40 |
| Medicom Self-seal Pouch | 305x457mm | 882350 | 2.59 |
| Medicom Self-seal Pouch | 305x492 mm | 882370 | 2.68 |
| K243431 | 510(K) SUMMARY | ||
| Medicom Self-seal Pouch | 350x483 mm | 882390 | 2.84 |
| Medicom Self-seal Pouch | 381x635 mm | 882400 | 3.06 |
| Medicom Self-seal Pouch | 381x727 mm | 882410 | 2.90 |
| Medicom Heat Seal Pouch | 89x159mm | 872010 | 0.27 |
| Medicom Heat Seal Pouch | 89x559 mm | 872030 | 1.17 |
| Medicom Heat Seal Pouch | 102x203 mm | 872050 | 0.45 |
| Medicom Heat Seal Pouch | 127x381 mm | 872080 | 1.14 |
| Medicom Heat Seal Pouch | 152x254 mm | 872090 | 0.91 |
| Medicom Heat Seal Pouch | 152x559 mm | 872120 | 1.90 |
| Medicom Heat Seal Pouch | 190x330 mm | 872130 | 1.46 |
| Medicom Heat Seal Pouch | 203x406 mm | 872150 | 1.85 |
| Medicom Heat Seal Pouch | 305x381 mm | 872180 | 2.40 |
| Medicom Heat Seal Pouch | 305x457 mm | 872190 | 2.68 |
| Medicom Heat Seal Pouch | 457x559 mm | 872220 | 2.96 |
| Medicom Flat Reel | 50mm x 30.5M | 952010 | 0.26 |
| Medicom Flat Reel | 75mm x 30.5M | 952020 | 0.56 |
| Medicom Flat Reel | 75mm x 200M | 952070 | 0.56 |
| Medicom Flat Reel | 100mm x 30.5M | 952030 | 0.84 |
| Medicom Flat Reel | 100mm x 200M | 952080 | 0.84 |
| Medicom Flat Reel | 150mm x 30.5M | 952040 | 1.38 |
| Medicom Flat Reel | 150mm x 200M | 952090 | 1.38 |
| Medicom Flat Reel | 200mm x 30.5M | 952050 | 1.88 |
| Medicom Flat Reel | 200mm x 200M | 952100 | 1.88 |
| Medicom Flat Reel | 250mm x 30.5M | 952060 | 2.35 |
| Medicom Flat Reel | 250mm x 200M | 952110 | 2.35 |
{17}------------------------------------------------
{18}------------------------------------------------
Device Description
The medical devices are inserted into the Medicom Sterilization Pouch and Reel, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Reel maintains the sterility of the enclosed medical devices until the seal is opened. And they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO).
The device is intended to allow the sterilization of enclosed devices and maintain sterility for the enclosed devices until used up to 1-year post-steam or EO gas sterilization.
The Self-seal pouch permits the sealing of the pouch without heat-sealing equipment, while the heat-sealed pouches and reels are heat-sealed before processing in the steam/or EO Sterilization.
The chemical indicators printed on the "medical grade paper" will exhibit color change after the pouch is exposed to steam or ethylene oxide gas. The "Medicom Sterilization Pouch and Reel" is printed with dual chemical indicators that the color change from Red/Pink to Cocoa when exposed to Steam, and the color changes from Blue to Golden Yellow /Brown, when exposed to EO gas.
The Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, but not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.
Furthermore, there are 3 thicknesses with dimensions for health care workers to choose from as follows:
- Pouch of Combination A: Medical grade paper 60g+laminated film 44um Dimensions of 880 series: W: 57mm ~ 415mm; L: 127mm
727mm Dimensions of 870 series: W: 89mm ~ 457mm; L: 159mm635mm Dimensions of 95 series: W: 50mm ~ 250mm; L: ~30.5M - Pouch of Combination B: Medical grade paper 60g+laminated film 52um Dimensions of 881 series: W: 57mm ~ 381mm; L: 127mm
797mm Dimensions of 871 series: W: 89mm ~ 457mm; L: 159mm559mm Dimensions of 951 series: W: 50mm ~ 250mm; L: ~200M - · Pouch of Combination C: Medical grade paper 70g+laminated film 52um Dimensions of 882 series: W: 57mm ~ 381mm; L: 127mm
797mm Dimensions of 872 series: W: 89mm ~ 457mm; L: 159mm559mm Dimensions of 952 series: W: 50mm ~ 250mm; L: ~200M
{19}------------------------------------------------
Description of Comparison and Substantial Equivalence
A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 5-4
| Feature | Proposed device | Predicate device | |
|---|---|---|---|
| Devicename | Medicom Sterilization Pouch and Reel | Safe Secure Sterilization Pouch with Steamand Ethylene Oxide (K153540) | Comparison |
| MaterialComposition | • Medical Grade Paper, CPP, PET, PU adhesive, EO andSteam Process Indicator, Print Ink., Double-side adhesive tape | Medical Grade Paper, CPP, PET, PU adhesive,EO and Steam Process Indicator, Print Ink. | Same. |
| Intendeduse | The Medicom Sterilization Pouch and Reel are intendedto provide health care workers with an effective methodto enclose devices, and they can use Single Pouch or Double Pouches intended for sterilization in the Steamor via Ethylene Oxide (EO).The recommended sterilization cycles are as follows:• Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.• Pre-vacuum steam at 132°C (270°F) for 4 minutes;Drying time of 20 minutes.• Pre-vacuum steam at 134°C (273°F) for 4 minutes;Drying time of 20 minutes.• Ethylene Oxide (EO) with a concentration of 600mg/L at 50°C (122°F) and 60% to 85% relative humidity for 120 minutes. Single Pouch: Aeration timeof 5 days at 25°C (77°F). Double Pouches: Aerationtime of 3 days at 25°C (77°F).Furthermore, there are 3 thicknesses for health care workers to choose from as follows:• Pouch of Combination A: Medical grade paper 60g+laminated film 44μm• Pouch of Combination B: Medical grade paper 60g+laminated film 52μm• Pouch of Combination C: Medical grade paper 70g+laminated film 52μmThe Medicom Sterilization Pouch and Reel which are made with Paper maintains the sterility of the enclosed devices for up to 1 year post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. | Safe Secure Paper Sterilization Pouches andRolls are intended to be used toenclose another medical device, in a single or double pouch configuration, that isto be sterilized by a health care provider using:• Gravity Steam at 121°C (250°F) for 30minutes; 25 minutes dry time• Pre-vacuum Steam at 132°C (270°F) for 4minutes; 20 minutes dry time• Pre-vacuum Steam at 134°C (273°F) for 3minutes; 20 minutes dry time• Pre-vacuum steam at 135°C (275°F) for 3minutes; 16 minutes dry time• Ethylene Oxide (EO) with a concentrationof 735 mg/L at 55°C (131°F) and 50% to80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).The device is not intended and has not been validated for sterilization of devices that contain lumens.The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the Steam or EO sterilization process and to distinguish between processed and unprocessed devices. The chemical indicators change from green to purple after exposure to steam and from yellow to brown after exposure to ethylene oxide. | Similarly, theSteam sterilizationof the proposed device increase byone cycle (Pre-vacuum 132°C/ 4 min).The proposed device is available in3 thicknesses for health care workers to choose. |
Table 5-4. Summary of the Proposed and Predicate Devices Technological Characteristics
{20}------------------------------------------------
K243431
510(K) SUMMARY
| Feature | Proposed device: Medicom SterilizationPouch and Reel | Predicate device: Safe Secure Steri-lization Pouch with Steam and Eth-ylene Oxide (K153540) | Comparison | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pouch Types | Combination A: Medical grade paper 60g+lami-nated film 44µmType:• Self-seal Pouch• Heat Seal Pouch• Flat ReelCombination B: Medical grade paper 60g+lami-nated film 52µmType:• Self-seal Pouch• Heat Seal Pouch• Flat ReelCombination C: Medical grade paper 70g+lami-nated film 52µmType:• Self-seal Pouch• Heat Seal Pouch• Flat Reel | Type:• Pouch paper heat seal• Tubing paper roll• Pouch multiple• Pouch paper self-seal | Similar, the predi-cate device has 1more type “Pouchmultiple”. | ||||||||
| Devicemodels(Configura-tions/Dimen-sions) | Combination A: Medical grade paper60g+laminated film 44µm | Pouch paper self-seal | Similar | ||||||||
| Self-seal Pouch Size Model W: 57 mm ~ 415mmL: 127 mm ~ 727mm 880 | Size Model W: 89 mm ~ 330 mmL:245 mm ~ 671mm ABSSP10 | ||||||||||
| Heat Seal Pouch Size Model W: 89 mm ~ 457mmL: 159 mm ~ 635mm 870 | Pouch paper heat seal Size Model W: 76 mm ~ 457mmL: 203 mm ~ 559mm ABHSP10 | Similar | |||||||||
| Flat Reel Size Model W: 50 mm ~ 250 mmL: ~ 30.5 M 95 | Tubing paper width 100FT Roll Size Model W: 51mm ~ 305 mmL: ~ 30.5 M ABHSP11 | Similar | |||||||||
| Combination B: Medical grade paper60g+laminated film 52µm | The proposed de-vice is available in3 thicknesses. | ||||||||||
| Self-seal Pouch Size Model W: 57 mm ~ 381mmL: 127 mm ~ 797mm 881 | N/A | ||||||||||
| Heat Seal Pouch Size Model W: 89 mm ~ 457mmL: 159 mm ~ 559mm 871 | N/A | ||||||||||
| Flat Reel Size Model W: 50 mm ~ 250 mmL: ~ 200 M 951 | N/A | The proposed de-vice is available in3 thicknesses. |
Table 5-4. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics
{21}------------------------------------------------
K243431
510(K) SUMMARY
| Combination C: Medical grade paper70g + laminated film 52µmSelf-seal Pouch | The proposed device is available in 3 thicknesses. | |||
|---|---|---|---|---|
| Size | Model | N/A | ||
| W: 57 mm ~ 381mmL: 127 mm ~ 797mm | 882 | |||
| Heat Seal Pouch | N/A | The proposed device is available in3 thicknesses. | ||
| Size | Model | |||
| W: 89 mm ~ 457mmL: 159 mm ~ 559mm | 872 | |||
| Flat Reel | N/A | The proposed device is available in3 thicknesses. | ||
| Size | Model | |||
| W: 50 mm ~ 250 mmL: ~ 200 M | 952 | |||
| SteamSterilizationcycle | The recommended steam sterilization parameters are as follows:The recommended sterilization cycles are as follows:• Gravity steam at 121°C (250°F) for 30 minutes;Drying time of 25 minutes.• Pre-vacuum steam at 132°C (270°F) for 4 minutes;Drying time of 20 minutes.• Pre-vacuum steam at 134°C (273°F) for 4 minutes;Drying time of 20 minutes. | The recommended steam sterilization parameters are as follows:• Gravity steam at 121°C (250°F) for 30minutes; 25 minutes dry time• Pre-vacuum steam at 132°C (270°F) for4 minutes; 20 minutes dry time• Pre-vacuum steam at 134°C (273°F) for3 minutes; 20 minutes dry timePre-vacuum steam at 135°C (275°F) for3 minutes; 16 minutes dry time | Similarly | |
| EO gasSterilizationcycle | The recommended EO sterilization parameters is as follows:• Ethylene Oxide (EO) with a concentration of 600mg/L at 50°C (122°F) and 60% to 85% relative humidity for 120 minutes. Single Pouch: Aerationtime of 5 days at 25°C (77°F). Double Pouches:Aeration time of 3 days at 25°C (77°F). | The recommended EO sterilization parameters is as follows:• Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and50% to 80% relative humidity for 60minutes. Aeration time of 8 hours at60°C (140°F). | Similarly | |
| DesignFeatures | Self-seal Pouch:These pouches are made of medical grade paper andplastic film with a double-side adhesive tape at theflap. The pouch is formed by heat-sealing on threesides, leaving the fourth side open allowing the usersto place devices for sterilization. The double-side adhesive tape is comprising of a tissue strip coated withacrylic adhesives and it is protected via a laminatedPE/paper/PE release paper which will firstly be removed allowing the sealing of the fourth side. Themedical grade paper conforms to recognized materialstandards and can be sterilized by steam or ethyleneoxide gas. The Process Indicators Ink printed on themedical grade paper will exhibit a color change afterthe pouch is exposed to steam or ethylene oxide gas.Heat Seal Pouch:These pouches has the same components with the Self-seal Pouch, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.Flat Reel:These reel made from a medical grade paper 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 medical grade paper are the same with the Self-seal Pouch. | Pouch paper self-seal:These pouches are made from a medical gradeplastic film that is heat sealed on three sides. Theforth side has an adhesive strip that is used to sealthe pouch. Release paper used in the pouch is alaminated sheet with composing structure ofPE/paper/PE. It is a strip to cover the adhesivearea and is released before seal the pouch. Themedical grade paper conforms to recognized material standards and can be sterilized by steam orethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit acolor change after the pouch is exposed to steamor ethylene oxide gas.Pouch paper Heat Seal:These pouches has the same components with the Pouch paper self-seal, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.Tubing paper roll:These reel made from a medical grade paper 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 medical grade paper are the same with the Pouch paper self-seal. | Similarly | |
| FeaturePerformance Testing | Proposed Device:Medicom SterilizationPouch and Reel | Predicate Devices:Safe Secure SterilizationPouch with Steam and Eth-ylene Oxide (K153540) | Comparison | |
| SterilantPenetration Half-Cycle Efficacy | The test meet the requirementof SAL 10-6 | The test meet the require-ment of SAL 10-6 | Same | |
| Chemical Indicator (CI) Func-tionality and Endpoint | The sterilant penetrated throughthe pouch configuration and af-fected the CI color change to theendpoint color | The sterilant penetrated throughthe pouch configuration and af-fected the CI color change to theendpoint color | Same | |
| Device Design of Steam CI | The color of Chemical Indicatorchanges from Red/Pink to Cocoa,when exposed to Steam. | The color of Chemical Indicatorchanges from green to purple,when exposed to Steam. | Similar | |
| Device Design of EO gas CI | The color changes from Blue toGolden Yellow /Brown, when ex-posed to EO gas. | The color changes from yellowto brown, when exposed to EOgas. | Similar | |
| Package In-tegrity(PhysicalProperties) | Thickness Variations (mm)ASTM F 2251 ; ISO 534 | Passed | Passed | Same |
| Tensile strength of paper* (kN/m;N/15mm) ISO 1924-2 | Passed | Passed | Same | |
| Air permeance of paper* (µm/(Pa · s)) ISO 5636-3 | Passed | Passed | Same | |
| Total Lead (Pb) Content Test | Passed (N.D.) | Not tested | Better | |
| Burst Strength (kPa)ASTM F1140 ; ISO 11607-1 | Passed | Passed | Same | |
| Bubble Leak TestASTM D 3078 ; ASTM-F 2096 | Passed | Passed | Same | |
| Seal Peel Test (N/15mm)ASTM F88/F88M ; ISO 11607-1 | Passed | Passed | Same | |
| Visual Inspection (Seal Integrity)ASTM F1886/F1886M; | Passed | Passed | Same | |
| Dye penetration TestASTM F 1929 ;ISO 11607-1 | Passed | Passed | Same | |
| Microbial Barrier TestDIN 58953-6 ;or ASTM F 1608 | Passed | Passed | Same | |
| Toxicological Properties(Biocompatibility Test)ANSI/AAMI/ISO 10993-10 | Passed | Passed | Same | |
| Accelerated Aging Test (Durability)ASTM F 1980 ; ISO 11607-1 | Passed | Passed | Same | |
| End Point /Post Pro-cessingColor Stabil-ity | After Steam sterilization | 1 Year | 6 months | Similar |
| After EO sterilization | 1 Year | 24 months | Similar | |
| Chemical Indicator (CI)Functionality | 3 Years | 5 Years | Similar | |
| Shelf Life | Accelerated aging test | 3 Years | 5 Years | Similar |
| Test completed | Standards followed | Acceptance criteria | Results | |
| Sterilant Penetration/Drying Time/ Aera-tion | ANSI/AAMI/ISO 17665-1:2006/(R)2013 | - Meet the requirement of SAL 10-6, thetest BI (the Steam processed): No bacte-rial growth-The weight difference before sterilizationand after drying shall not exceed 0 % | Pass | |
| ANSI/AAMI/ISO TIR 17665-2:2009 (R2016) | ||||
| AAMI / ANSI / ISO11135:2014 | Meet the requirement of SAL 10-6, the testBI (the EO processed): No bacterialgrowth | Pass | ||
| ISO 10993-7:2008 (R) 2012 | EO ≤ 4mgECH ≤ 9mg | Pass | ||
| Biocompatibilitytesting | ISO 10993-5 :2009 | Grade level ≤ 2 | Pass | |
| ISO 10993-10:2021 | Sensitization rate ≤ 8 % | Pass | ||
| ISO 10993-23:2021 | Non-irritating: mean PII ≤ 0.4 | Pass | ||
| Package Integrity/Material Compatibil-ity/ Sterility Mainte-nance | ANSI/AAMI/ISO 11607-1:2019-02 | |||
| ISO 1924-2:2008 | Machine direction (MD) ≥ 4.4 kN/mCross direction (CD) ≥ 2.2 kN/m | Pass | ||
| ISO 5636-3:2013 | ≥ 3.4 $\mu$ m /Pa · s | Pass | ||
| ASTM F 2251-13(2018) | Medical grade paper ≥ 78µm | Pass | ||
| ASTM F1886/F1886M -16 | No visual defects | Pass | ||
| ASTM F1140/F1140M-13(Reapproved 2020) | Self-seal pouches: ≥ 8.0 in. H2OHeat Seal pouches: ≥ 8.0 in. H2OFlat reels: ≥ 18.0 in. H2O | Pass | ||
| ASTM F1929-15 | No leaks | Pass |
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510(K) SUMMARY
Table 5-4. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics
Note: *the test items were performed on materials of the products; there is no specification requirements.
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Summary of Non-Clinical Testing
The Medicom Sterilization Pouch and Reel has the identical intended use and indication for use as the predicate devices. The subject device was compared to the predicate device by testing the Sterilant Penetration, Drying Time, Aeration, Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance, and Chemical Indicator Efficacy.
The results of the Medicom Sterilization Pouch and Reel validation studies demonstrate that the sterilization pouches perform as intended. The results are summarized as following Table 5-5:
| Table 5-5. Summary of Non-Clinical Testing | |
|---|---|
| -------------------------------------------- | -- |
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K243431
510(K) SUMMARY
| Package Integrity/Material Compatibil-ity/ Sterility Maintenance | ASTM F88/F88M-21 | • Post-steam /EO sterilization:$≥ 1.5N/15mm (≥ 0.57 lbf/inch)$ | Pass |
|---|---|---|---|
| ASTM F 1980-21 | 3-Year accelerated aging Incubation:Range of Actual Value: Temp: 55°C± 2°C,Relative humidity 50%± 5%1 Year accelerated aging Incubation:Range of Actual Value: Temp: 55°C± 2°C,Relative humidity 50%± 5% | Pass | |
| ASTM F2096-11(Reapproved2019) | No gross leaks | Pass | |
| ASTM F1608-21 | LRV ≥ 1.0 | Pass | |
| Chemical IndicatorEfficacy testing(Type 1 Indicators) | AAMI/ANSI/ISO 11140-1:2014 | • Change the color: (Steam)• 121°C / 2.0 min & 132°C / 0.3 min & 134°C/ 0.3 min : Unacceptable result (Color:Red/Pink)• 121°C/10.0 min & 132°C / 2.0 min & 134°C / 2.0 min : Acceptable result (Color: Cocoa)Dry heat 140°C/30 min: Unacceptable result (Color: Red/Pink)Note: The color of CI changes fromRed/Pink to Cocoa, when exposed toSteam. | Pass |
| • Change the color: (EO gas)• EO gas Treat / 2 min: Unacceptable result(Color: Blue)• EO gas Treat /20 min: Acceptable result(Color: Golden Yellow /Brown)Absence of EO gas / 90 min: Unacceptable result (Color: Blue)Note: The color of CI changes from Blue toGolden Yellow /Brown, when exposed toEO gas. | Pass | ||
| • Shelf life:Remain stable before use based on itsshelf life for 3 years. | Pass | ||
| • Maintain the endpoint stability:Maintain the endpoint stability of thecolor change for 1 year after being in thepresence of the sterilant. | Pass | ||
| Total Lead (Pb) Test | Not Detected (N.D.) | Pass |
CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that Medicom Sterilization Pouch and Reel is as safe, as effective, and performs as well as or better than the predicate K153540.
§ 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).