Medicom Sterilization Pouch and Reel

K243431 · Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. · FRG · Feb 21, 2025 · General Hospital

Device Facts

• Record ID: K243431
• Device Name: Medicom Sterilization Pouch and Reel
• Applicant: Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.
• Product Code: FRG · General Hospital
• Decision Date: Feb 21, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

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 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.

Device Story

Medicom Sterilization Pouch and Reel are packaging systems for medical devices undergoing sterilization. Components include medical-grade paper, laminated film (CPP/PET), and PU adhesive. Available as self-seal pouches (with adhesive strip), heat-seal pouches, or flat reels. Users place devices inside, seal the pouch (via adhesive or heat-sealing equipment), and process in steam or EO sterilization cycles. External chemical indicators printed on the paper change color (Red/Pink to Cocoa for steam; Blue to Golden Yellow/Brown for EO) to confirm exposure to the sterilization process. Used in clinical settings by healthcare workers. Maintains sterility of enclosed devices for up to 1 year post-sterilization. Benefits include effective containment and sterility maintenance of instruments, with visual confirmation of processing.

Clinical Evidence

Bench testing only. Validation included sterilant penetration (SAL 10^-6), drying time, aeration, biocompatibility (ISO 10993-5, -10, -23), package integrity (burst, bubble leak, seal peel, dye penetration), and chemical indicator efficacy per ISO 11140-1. All tests passed.

Technological Characteristics

Materials: Medical grade paper, CPP, PET, PU adhesive. Dimensions: Various widths (50-457mm) and lengths. Sterilization: Steam (Gravity/Pre-vacuum) and EO. Chemical indicators: Type 1 process indicators. Connectivity: N/A. Software: None.

Indications for Use

Indicated for health care workers to enclose medical devices for sterilization via steam or ethylene oxide (EO) gas. Suitable for single or double pouch configurations. Not validated for devices containing lumens.

Regulatory Classification

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.

Predicate Devices

• Safe Secure Sterilization Pouch with Steam and Ethylene Oxide (K153540)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 |

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#### 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)

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## 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<br>County 26841, Taiwan |
| Establishment<br>Registration Number: | 3008132392 |
| Contact: | Henry Chu<br>General Manager<br>TEL: [phone]<br>email: [e-mail]<br>email: [e-mail] |
| 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.<br>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 880.6850<br>2) 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.

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### 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.):

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#### 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: 159mm~635mm 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: 159mm~559mm 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: 159mm~559mm 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<br>name | Medicom Sterilization Pouch and Reel | Safe Secure Sterilization Pouch with Steam<br>and Ethylene Oxide (K153540) | Comparison |
| Material<br>Composition | • Medical Grade Paper, CPP, PET, PU adhesive, EO and<br>Steam Process Indicator, Print Ink., Double-side adhesive tape | Medical Grade Paper, CPP, PET, PU adhesive,<br>EO and Steam Process Indicator, Print Ink. | Same. |
| Intended<br>use | The Medicom Sterilization Pouch and Reel are intended<br>to provide health care workers with an effective method<br>to enclose devices, and they can use Single Pouch or Double Pouches intended for sterilization in the Steam<br>or via Ethylene Oxide (EO).<br>The recommended sterilization cycles are as follows:<br>• Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.<br>• Pre-vacuum steam at 132°C (270°F) for 4 minutes;<br>Drying time of 20 minutes.<br>• Pre-vacuum steam at 134°C (273°F) for 4 minutes;<br>Drying time of 20 minutes.<br>• Ethylene Oxide (EO) with a concentration of 600<br>mg/L at 50°C (122°F) and 60% to 85% relative humidity for 120 minutes. Single Pouch: Aeration time<br>of 5 days at 25°C (77°F). Double Pouches: Aeration<br>time of 3 days at 25°C (77°F).<br>Furthermore, there are 3 thicknesses for health care workers to choose from as follows:<br>• Pouch of Combination A: Medical grade paper 60g+laminated film 44μm<br>• Pouch of Combination B: Medical grade paper 60g+laminated film 52μm<br>• Pouch of Combination C: Medical grade paper 70g+laminated film 52μm<br>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<br>Rolls are intended to be used to<br>enclose another medical device, in a single or double pouch configuration, that is<br>to be sterilized by a health care provider using:<br>• Gravity Steam at 121°C (250°F) for 30<br>minutes; 25 minutes dry time<br>• Pre-vacuum Steam at 132°C (270°F) for 4<br>minutes; 20 minutes dry time<br>• Pre-vacuum Steam at 134°C (273°F) for 3<br>minutes; 20 minutes dry time<br>• Pre-vacuum steam at 135°C (275°F) for 3<br>minutes; 16 minutes dry time<br>• Ethylene Oxide (EO) with a concentration<br>of 735 mg/L at 55°C (131°F) and 50% to<br>80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).<br>The device is not intended and has not been validated for sterilization of devices that contain lumens.<br>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<br>Steam sterilization<br>of the proposed device increase by<br>one cycle (Pre-<br>vacuum 132°C/ 4 min).<br>The proposed device is available in<br>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<br>Pouch and Reel | Predicate device: Safe Secure Steri-<br>lization Pouch with Steam and Eth-<br>ylene Oxide (K153540) | Comparison | | | | | | | | |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|--|--|--------------------------------------------------------------------------------------|------------------------------------------------------------|--|--|--|---------|
| Pouch Types | Combination A: Medical grade paper 60g+lami-<br>nated film 44µm<br>Type:<br>• Self-seal Pouch<br>• Heat Seal Pouch<br>• Flat Reel<br>Combination B: Medical grade paper 60g+lami-<br>nated film 52µm<br>Type:<br>• Self-seal Pouch<br>• Heat Seal Pouch<br>• Flat Reel<br>Combination C: Medical grade paper 70g+lami-<br>nated film 52µm<br>Type:<br>• Self-seal Pouch<br>• Heat Seal Pouch<br>• Flat Reel | Type:<br>• Pouch paper heat seal<br>• Tubing paper roll<br>• Pouch multiple<br>• Pouch paper self-seal | Similar, the predi-<br>cate device has 1<br>more type “Pouch<br>multiple”. | | | | | | | | |
| Device<br>models<br>(Configura-<br>tions/Dimen-<br>sions) | Combination A: Medical grade paper<br>60g+laminated film 44µm | Pouch paper self-seal | Similar | | | | | | | | |
| | Self-seal Pouch Size Model W: 57 mm ~ 415mm<br>L: 127 mm ~ 727mm 880 | | | | | | Size Model W: 89 mm ~ 330 mm<br>L:245 mm ~ 671mm ABSSP10 | | | | |
| | Heat Seal Pouch Size Model W: 89 mm ~ 457mm<br>L: 159 mm ~ 635mm 870 | | | | | Pouch paper heat seal Size Model W: 76 mm ~ 457mm<br>L: 203 mm ~ 559mm ABHSP10 | | | | | Similar |
| | Flat Reel Size Model W: 50 mm ~ 250 mm<br>L: ~ 30.5 M 95 | | | | | Tubing paper width 100FT Roll Size Model W: 51mm ~ 305 mm<br>L: ~ 30.5 M ABHSP11 | | | | | Similar |
| | Combination B: Medical grade paper<br>60g+laminated film 52µm | | The proposed de-<br>vice is available in<br>3 thicknesses. | | | | | | | | |
| | Self-seal Pouch Size Model W: 57 mm ~ 381mm<br>L: 127 mm ~ 797mm 881 | | | | | | N/A | | | | |
| | Heat Seal Pouch Size Model W: 89 mm ~ 457mm<br>L: 159 mm ~ 559mm 871 | | | | | | N/A | | | | |
| | Flat Reel Size Model W: 50 mm ~ 250 mm<br>L: ~ 200 M 951 | | | | | N/A | The proposed de-<br>vice is available in<br>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<br>70g + laminated film 52µm<br>Self-seal Pouch | | | | The proposed device is available in 3 thicknesses. |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…