(108 days)
Not Found
No
The device is a physical sterilization pouch with chemical indicators, and the description focuses on material properties, sterilization cycles, and physical dimensions. There is no mention of software, data processing, or any technology that would involve AI or ML.
No
The device is a sterilization packaging material designed to enclose and maintain the sterility of other medical devices, not to provide a therapeutic effect itself. Its function is to facilitate the sterilization process and protect the sterilized medical devices.
No
The device is a sterilization pouch and reel intended to enclose other medical devices for sterilization and maintain their sterility. It includes chemical indicators to show exposure to sterilization agents, but it does not diagnose a condition or disease.
No
The device is a physical product (pouches and reels) made of paper and laminated film, intended for enclosing medical devices for sterilization. It includes physical components like chemical indicators.
Based on the provided text, the Medicom Sterilization Pouch and Reel is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as providing a method to enclose devices for sterilization in Steam or Ethylene Oxide and maintaining their sterility. This is a function related to the sterilization and storage of medical devices, not the diagnosis of diseases or conditions using in vitro methods.
- Device Description: The description focuses on the physical characteristics of the pouches and reels, their ability to withstand sterilization processes, maintain sterility, and the function of the chemical indicators to show exposure to sterilization agents. None of these functions relate to in vitro diagnostic testing.
- Lack of IVD Characteristics: The text does not mention any components or functions typically associated with IVD devices, such as reagents, calibrators, controls, or the analysis of biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Predicate Device: The predicate device listed (K153540, Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators) is also a sterilization pouch, further supporting that this device type is not classified as an IVD.
Therefore, the Medicom Sterilization Pouch and Reel is a medical device used for the sterilization and storage of other medical devices, not an in vitro diagnostic device.
N/A
Intended Use / 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 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 user that the pouch has undergone either a steam or EO sterilization process.
Product codes (comma separated list FDA assigned to the subject device)
FRG, JOJ
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care workers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing included:
- Sterilant Penetration/Drying Time/Aeration: Tested against ANSI/AAMI/ISO 17665-1:2006/(R)2013, ANSI/AAMI/ISO TIR 17665-2:2009 (R2016), AAMI / ANSI / ISO 11135:2014, and ISO 10993-7:2008 (R) 2012. Results met SAL 10-6 requirement (no bacterial growth) for steam and EO processes, and showed proper EO and ECH levels.
- Biocompatibility testing: Tested against ISO 10993-5 :2009, ISO 10993-10:2021, and ISO 10993-23:2021. Results showed Grade level
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo 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.
1
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
2
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
3
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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4
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)
5
6
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, Yilan |
| County 26841, Taiwan | |
| Establishment | |
| Registration Number: | 3008132392 |
| Contact: | Henry Chu |
| General Manager | |
| TEL: +886-3-990-9100 | |
| email: hchu@medicom-taiwan.com | |
| email: 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. |
- 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 880.6850 - 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 | |
|---|---|---|---|
| Device | |||
| name | Medicom Sterilization Pouch and Reel | Safe Secure Sterilization Pouch with Steam | |
| and Ethylene Oxide (K153540) | Comparison | ||
| Material | |||
| Composition | • Medical Grade Paper, CPP, PET, PU adhesive, EO and | ||
| Steam Process Indicator, Print Ink., Double-side adhesive tape | Medical Grade Paper, CPP, PET, PU adhesive, | ||
| EO and Steam Process Indicator, Print Ink. | Same. | ||
| Intended | |||
| 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 44μm | |||
| • Pouch of Combination B: Medical grade paper 60g+laminated film 52μm | |||
| • Pouch of Combination C: Medical grade paper 70g+laminated film 52μm | |||
| 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. | Safe Secure Paper Sterilization Pouches and | ||
| Rolls are intended to be used to | |||
| enclose another medical device, in a single or double pouch configuration, that is | |||
| to be sterilized by a health care provider using: | |||
| • Gravity Steam at 121°C (250°F) for 30 | |||
| minutes; 25 minutes dry time | |||
| • Pre-vacuum Steam at 132°C (270°F) for 4 | |||
| minutes; 20 minutes dry time | |||
| • Pre-vacuum Steam at 134°C (273°F) for 3 | |||
| minutes; 20 minutes dry time | |||
| • Pre-vacuum steam at 135°C (275°F) for 3 | |||
| minutes; 16 minutes dry time | |||
| • Ethylene Oxide (EO) with a concentration | |||
| of 735 mg/L at 55°C (131°F) and 50% to | |||
| 80% 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, the | ||
| Steam sterilization | |||
| of the proposed device increase by | |||
| one cycle (Pre- | |||
| vacuum 132°C/ 4 min). | |||
| The proposed device is available in | |||
| 3 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 Sterilization
Pouch 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 44µm
Type:
• Self-seal Pouch
• Heat Seal Pouch
• Flat Reel
Combination B: Medical grade paper 60g+lami-
nated film 52µm
Type:
• Self-seal Pouch
• Heat Seal Pouch
• Flat Reel
Combination C: Medical grade paper 70g+lami-
nated film 52µm
Type:
• 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 1
more type “Pouch
multiple”. | | | | | | | | |
| Device
models
(Configura-
tions/Dimen-
sions) | Combination A: Medical grade paper
60g+laminated film 44µm | Pouch paper self-seal | Similar | | | | | | | | |
| | Self-seal Pouch Size Model W: 57 mm ~ 415mm
L: 127 mm ~ 727mm 880 | | | | | | Size Model W: 89 mm ~ 330 mm
L:245 mm ~ 671mm ABSSP10 | | | | |
| | Heat Seal Pouch Size Model W: 89 mm ~ 457mm
L: 159 mm ~ 635mm 870 | | | | | Pouch paper heat seal Size Model W: 76 mm ~ 457mm
L: 203 mm ~ 559mm ABHSP10 | | | | | Similar |
| | Flat Reel Size Model W: 50 mm ~ 250 mm
L: ~ 30.5 M 95 | | | | | Tubing paper width 100FT Roll Size Model W: 51mm ~ 305 mm
L: ~ 30.5 M ABHSP11 | | | | | Similar |
| | Combination B: Medical grade paper
60g+laminated film 52µm | | The proposed de-
vice is available in
3 thicknesses. | | | | | | | | |
| | Self-seal Pouch Size Model W: 57 mm ~ 381mm
L: 127 mm ~ 797mm 881 | | | | | | N/A | | | | |
| | Heat Seal Pouch Size Model W: 89 mm ~ 457mm
L: 159 mm ~ 559mm 871 | | | | | | N/A | | | | |
| | Flat Reel Size Model W: 50 mm ~ 250 mm
L: ~ 200 M 951 | | | | | N/A | The proposed de-
vice is available in
3 thicknesses. | | | | |
Table 5-4. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics
21
K243431
510(K) SUMMARY
| Combination C: Medical grade paper
70g + laminated film 52µm
| Self-seal Pouch | The proposed device is available in 3 thicknesses. | |||
|---|---|---|---|---|
| Size | Model | N/A | ||
| W: 57 mm ~ 381mm | ||||
| L: 127 mm ~ 797mm | 882 | |||
| Heat Seal Pouch | N/A | The proposed device is available in | ||
| 3 thicknesses. | ||||
| Size | Model | |||
| W: 89 mm ~ 457mm | ||||
| L: 159 mm ~ 559mm | 872 | |||
| Flat Reel | N/A | The proposed device is available in | ||
| 3 thicknesses. | ||||
| Size | Model | |||
| W: 50 mm ~ 250 mm | ||||
| L: ~ 200 M | 952 | |||
| Steam | ||||
| Sterilization | ||||
| cycle | 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 30 | ||||
| minutes; 25 minutes dry time | ||||
| • Pre-vacuum steam at 132°C (270°F) for | ||||
| 4 minutes; 20 minutes dry time | ||||
| • Pre-vacuum steam at 134°C (273°F) for | ||||
| 3 minutes; 20 minutes dry time | ||||
| Pre-vacuum steam at 135°C (275°F) for | ||||
| 3 minutes; 16 minutes dry time | Similarly | |||
| EO gas | ||||
| Sterilization | ||||
| cycle | The recommended EO sterilization parameters is as follows: | |||
| • 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). | The recommended EO sterilization parameters is as follows: | |||
| • Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and | ||||
| 50% to 80% relative humidity for 60 | ||||
| minutes. Aeration time of 8 hours at | ||||
| 60°C (140°F). | Similarly | |||
| Design | ||||
| Features | Self-seal Pouch: | |||
| These pouches are made of medical grade paper and | ||||
| plastic film with a double-side adhesive tape at the | ||||
| flap. The pouch is formed by heat-sealing on three | ||||
| sides, leaving the fourth side open allowing the users | ||||
| to place devices for sterilization. The double-side adhesive tape is comprising of a tissue strip coated with | ||||
| acrylic adhesives and it is protected via a laminated | ||||
| PE/paper/PE release paper which will firstly be removed allowing the sealing of the fourth side. The | ||||
| medical grade paper conforms to recognized material | ||||
| standards and can be sterilized by steam or ethylene | ||||
| oxide gas. The Process Indicators Ink printed on the | ||||
| medical grade paper will exhibit a color change after | ||||
| the 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 grade | ||||
| plastic film that is heat sealed on three sides. The | ||||
| forth side has an adhesive strip that is used to seal | ||||
| the pouch. Release paper used in the pouch is a | ||||
| laminated sheet with composing structure of | ||||
| PE/paper/PE. It is a strip to cover the adhesive | ||||
| area and is released before seal the pouch. The | ||||
| medical grade paper conforms to recognized material standards and can be sterilized by steam or | ||||
| ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a | ||||
| color change after the pouch is exposed to steam | ||||
| or 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 | |||
| Feature | ||||
| Performance Testing | Proposed Device: | |||
| Medicom Sterilization | ||||
| Pouch and Reel | Predicate Devices: | |||
| Safe Secure Sterilization | ||||
| Pouch with Steam and Eth- | ||||
| ylene Oxide (K153540) | Comparison | |||
| Sterilant | ||||
| Penetration Half-Cycle Efficacy | The test meet the requirement | |||
| of SAL 10-6 | The test meet the require- | |||
| ment of SAL 10-6 | Same | |||
| Chemical Indicator (CI) Func- | ||||
| tionality and Endpoint | The sterilant penetrated through | |||
| the pouch configuration and af- | ||||
| fected the CI color change to the | ||||
| endpoint color | The sterilant penetrated through | |||
| the pouch configuration and af- | ||||
| fected the CI color change to the | ||||
| endpoint color | Same | |||
| Device Design of Steam CI | The color of Chemical Indicator | |||
| changes from Red/Pink to Cocoa, | ||||
| when exposed to Steam. | The color of Chemical Indicator | |||
| changes from green to purple, | ||||
| when exposed to Steam. | Similar | |||
| Device Design of EO gas CI | The color changes from Blue to | |||
| Golden Yellow /Brown, when ex- | ||||
| posed to EO gas. | The color changes from yellow | |||
| to brown, when exposed to EO | ||||
| gas. | Similar | |||
| Package In- | ||||
| tegrity | ||||
| (Physical | ||||
| Properties) | 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 Test | ||||
| ASTM 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 Test | ||||
| ASTM F 1929 ;ISO 11607-1 | Passed | Passed | Same | |
| Microbial Barrier Test | ||||
| DIN 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- | ||||
| cessing | ||||
| Color 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, the | |||
| test BI (the Steam processed): No bacte- | ||||
| rial growth | ||||
| -The weight difference before sterilization | ||||
| and after drying shall not exceed 0 % | Pass | |||
| ANSI/AAMI/ISO TIR 17665- | ||||
| 2:2009 (R2016) | ||||
| AAMI / ANSI / ISO | ||||
| 11135:2014 | Meet the requirement of SAL 10-6, the test | |||
| BI (the EO processed): No bacterial | ||||
| growth | Pass | |||
| ISO 10993-7:2008 (R) 2012 | EO ≤ 4mg | |||
| ECH ≤ 9mg | Pass | |||
| Biocompatibility | ||||
| testing | 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/m | |||
| Cross 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. H2O | |||
| Heat Seal pouches: ≥ 8.0 in. H2O | ||||
| Flat reels: ≥ 18.0 in. H2O | Pass | |||
| ASTM F1929-15 | No leaks | Pass |
22
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.
23
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 | |
|---|---|
| -------------------------------------------- | -- |
24
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(Reapproved
2019) | No gross leaks | Pass |
| | ASTM F1608-21 | LRV ≥ 1.0 | Pass |
| Chemical Indicator
Efficacy 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 from
Red/Pink to Cocoa, when exposed to
Steam. | 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 to
Golden Yellow /Brown, when exposed to
EO gas. | Pass |
| | | • Shelf life:
Remain stable before use based on its
shelf life for 3 years. | Pass |
| | | • Maintain the endpoint stability:
Maintain the endpoint stability of the
color change for 1 year after being in the
presence 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.