STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

K220345 · Plasmapp Co,., Ltd. · MLR · Apr 14, 2023 · General Hospital

Device Facts

• Record ID: K220345
• Device Name: STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
• Applicant: Plasmapp Co,., Ltd.
• Product Code: MLR · General Hospital
• Decision Date: Apr 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

The STERLINK mini sterilizer with STERLOAD™ mini cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low pressure and low temperature and is thus suitable for processing medical devices sensitive to heat and moisture. The STERLINK mini can sterilize: • Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors • Medical devices with a single stainless-steel lumen with: o An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter *The validation testing for all lumen sizes was conducted using a maximum of five (5) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load with a total weight of 1.54 lbs.

Device Story

STERLINK mini is a low-temperature, vaporized hydrogen peroxide sterilizer for healthcare facilities. System comprises main unit, pump module, and STERLOAD mini cassette (58-59.5% H2O2). Operates via pre-programmed vacuum-based cycle (approx. 18 mins) at 60°C. Input: cleaned/rinsed/dried medical devices. Output: terminally sterilized devices. Used by healthcare staff to process heat/moisture-sensitive instruments. Output verified by chemical/biological indicators. Benefits: rapid, safe, effective sterilization of sensitive devices.

Clinical Evidence

No clinical data. Bench testing only. Validated per ISO 14937, ISO 11138-1, ISO 10993-5, and ASTM standards. Primary endpoints: Sterility Assurance Level (SAL) ≥ 10^-6, material compatibility, and sporicidal activity. All tests passed.

Technological Characteristics

Vaporized hydrogen peroxide sterilizer. Materials: Welded frame, stainless steel chamber. Sensing: Thermocouples (chamber/vaporizer), pressure transducers. Connectivity: Standalone. Software: Embedded Linux. Sterilant: 58-59.5% H2O2 aqueous solution (unit dose cassette). Dimensions: 7L chamber. Power: 1000W.

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices in healthcare facilities. Suitable for heat/moisture-sensitive devices, including instruments with diffusion-restricted spaces (e.g., hinged forceps/scissors) and single stainless-steel lumens (ID ≥ 1.6 mm, length ≤ 200 mm). Max load 1.54 lbs; max 5 lumens per load.

Regulatory Classification

Identification

An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.

Predicate Devices

• STERLINK FPS-15s Plus (K212200)
• Tyvek Roll with CI for STERLINK Sterilizer (K212198)
• Terragene Bionova SCBI (BT96) (K212193)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 14, 2023

Plasmapp Co., Ltd. % Candace Cederman Consultant CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401

Re: K220345

Trade/Device Name: STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR, FRG, JOJ, FRC Dated: February 25, 2022 Received: February 28, 2022

Dear Candace Cederman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Christopher K. Duqard -2

for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K220345

Device Name

STERLINK mini Sterilizer with STERLOAD™ mini Cassette

Indications for Use (Describe)

The STERLINK mini sterilizer with STERLOAD™ mini cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low temperature and is thus suitable for processing medical devices sensitive to heat and moisture.

The STERLINK mini can sterilize *:

- · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- · Medical devices with a single stainless-steel lumen with:
- o An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter

*The validation testing was conducted using a maximum of five (5) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load with a total weight of 1.54 lbs.

| Type of Use (Select one or both, as applicable) | <div> <span> <input type="checkbox"/> </span> <span> <input checked="" type="checkbox"/> </span> </div> |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------|

| | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# Indications for Use

510(k) Number (if known)

### K220345

Device Name Tyvek® Roll with CI for STERLINK™ Sterilizer

### Indications for Use (Describe)

Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.

The materials compatible for use in the Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in Chamber mode, are as follows: Aluminum 5052, Aluminum 6061, Stainless Steel 316L, Titanium, Acrylonitrile Butadiene Styrene (ABS), High Density Polyethylene (HDPE), Polypropylene (PP), Polytetrafluoroethylene (PTFE) and Silicone (Hardness 50).

The maximum load weight that can be placed in the Tyvek® roll is:

- · 3.97 pounds (1.8 kg) for CHAMBER mode of FPS-15s Plus sterilizer
- · 1.54 pounds (0.7 kg) for CHAMBER mode of STERLINK mini sterilizer

The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140 1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.

The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow 1 type: · Sterilization roll, Flat

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <div></div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div></div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# Indications for Use

## 510(k) Number (if known) K220345

Device Name

Sterilization Process Indicator for STERLINK™ Sterilizer

Terragene Bionova® SCBI (BT96), Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye® (CD42), Terragene Cintape® (CT40)

### Indications for Use (Describe)

Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 10% Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.

Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.

Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow for CD42 to indicate that the conditions of the cycle have been met.

Terragene Cintape® (CT40) is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

The self-contained biological indicator and chemical processing indicators are intended for use with:

- · CHAMBER mode of FPS-15s Plus sterilizer
- · CHAMBER mode of STERLINK mini sterilizer

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/5/Picture/2 description: The image shows the word "plasmapp" in a teal color. There is a teal asterisk to the left of the word. The font is sans-serif and the letters are lowercase.

510(k) Summary [as required by 21 CFR 807.92(c)]

STERLINK mini Sterilizer with STERLOAD™ mini Cassette Tyvek® Roll with CI for STERLINK™ Sterilizer Sterilization Process Indicator for STERLINK™ Sterilizer

510(k) K220345

## General Information

| Applicant/Submitter: | Plasmapp Co., Ltd.<br>BVC-111, 125, Gwahak-ro,<br>Yuseong-gu, Daejeon, 34141,<br>Rep. of Korea (South Korea)<br>Tel: [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Candace Cederman |
| Address: | CardioMed Device Consultants LLC<br>1783 Forest Drive, Suite 254<br>Annapolis, MD 21401<br>Tel: [phone] |
| Preparation Date: | April 13, 2023 |

## Device Name and Code

| Device Trade Name: | A. STERLINK mini Sterilizer with STERLOAD™ mini Cassette<br>B. Tyvek® Roll with CI for STERLINK™ Sterilizer<br>C. Sterilization Process Indicator for STERLINK™ Sterilizer;<br>Terragene Bionova® SCBI (BT96); Terragene Bionova®<br>Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene<br>Chemdye® (CD42); Terragene Cintape® (CT40) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | A. Vapor Phase Hydrogen Peroxide Sterilization System<br>B. Tyvek® Roll for VH2O2 Sterilizer<br>C. Self-contained Biological Indicator, Self-Contained Biological<br>Indicator Incubator, Chemical Indicator. |

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| Classification Name: | A. Ethylene Oxide Gas Sterilizer<br>B. Sterilization Wrap<br>C. Sterilization Process Indicator |
|----------------------|-------------------------------------------------------------------------------------------------|
| Product Code: | A. MLR<br>B. FRG, JOJ<br>C. FRC, JOJ |
| Regulation Number: | A. 21 CFR 880.6860<br>B. 21 CFR 880.6850, 21 CFR 880.2800<br>C. 21 CFR 880.2800 |
| Classification: | Class II |
| Review Panel: | General Hospital |

#### STERLINK mini Sterilizer with STERLOAD™ mini Cassette A.

#### Device Description A.1

The STERLINK mini sterilizer with STERLOAD™ mini cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of medical devices and instruments. This sterilizer offers an effective, safe, fast, economical, easy to use, reliable, and flexible sterilization method.

This system consists of a main device connected pump module and cassette which are called the STERLINK mini and STERLOAD™ mini cassette, respectively. The STERLOAD™ mini cassette contains 58-59.5% (weight concentration) of hydrogen peroxide (H2O2) which is utilized as the sterilant.

#### A.2 Indications / Intended Use

The subject and predicate device have the same intended use. The specific indications for use differ only in the size and weight of the medical devices that can be sterilized in each chamber.

The STERLINK mini sterilizer with STERLOAD™ mini cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed

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sterilization cycle operates at low pressure and low temperature and is thus suitable for processing medical devices sensitive to heat and moisture.

- I The STERLINK mini can sterilize*:
- Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- · Medical devices with a single stainless-steel lumen with:

o An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter

*The validation testing for all lumen sizes was conducted using a maximum of five (5) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load with a total weight of 1.54 lbs.

#### A.3 Technical Characteristics in Comparison to Predicate Devices

A summary of the technical characteristics of the subject device and predicate device can be found in the table below.

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| | Subject Device | Predicate Device | Comparison |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| | Plasmapp Co., Ltd. | Plasmapp Co., Ltd. | Same |
| Device Name | STERLINK mini | FPS-15s Plus | - |
| 510(k) Number | | K212200 | - |
| Device<br>Classification<br>Name | Ethylene oxide gas sterilizer | Ethylene oxide gas sterilizer | Same |
| Classification<br>Product Code | MLR | MLR | Same |
| Regulation<br>Number | 21 CFR 880.6860 | 21 CFR 880.6860 | Same |
| Intended Use | The STERLINK mini sterilizer with STERLOADTM<br>mini cassette is a vaporized hydrogen peroxide<br>sterilizer intended for use in the terminal sterilization<br>of cleaned, rinsed, and dried reusable metal and<br>nonmetal medical devices used in healthcare<br>facilities. A pre-programmed sterilization lumen cycle<br>operates at low pressure and low temperature and is<br>thus suitable for processing medical devices sensitive<br>to heat and moisture.<br><br>The STERLINK mini can sterilize*:<br>• Instruments with diffusion-restricted spaces such as<br>the hinged portion of forceps and scissors<br>• Medical devices with a single stainless-steel lumen<br>with:<br>o An inside diameter of 1.6 mm or larger and a<br>length of 200 mm or shorter<br><br>*The validation testing for all lumen sizes was<br>conducted using a maximum of five (5) lumens per<br>load. Hospital loads should not exceed the maximum<br>number of lumens validated by this testing. The | The STERLINKTM FPS-15s Plus sterilizer with<br>STERLOADTM cassette is a vaporized hydrogen<br>peroxide sterilizer intended for use in the terminal<br>sterilization of cleaned, rinsed, and dried reusable<br>metal and nonmetal medical devices used in healthcare<br>facilities. A pre-programmed sterilization lumen cycle<br>operates at low pressure and low temperature and is<br>thus suitable for processing medical devices sensitive<br>to heat and moisture.<br><br>The STERLINKTM FPS-15s Plus can sterilize*:<br>• Instruments with diffusion-restricted spaces such as<br>the hinged portion of forceps and scissors<br>• Medical devices with a single stainless-steel lumen<br>with:<br>o An inside diameter of 2.4 mm or larger and a<br>length of 280 mm or shorter<br><br>*The validation testing for all lumen sizes was<br>conducted using a maximum of five (5) lumens per<br>load. Hospital loads should not exceed the maximum<br>number of lumens validated by this testing. The | Similar;<br>Intended Use is the<br>same with the<br>exception of the<br>maximum load and<br>lumen specification |
| | Subject Device | Predicate Device | Comparison |
| | Plasmapp Co., Ltd. | Plasmapp Co., Ltd. | Same |
| | validation studies were performed using a validation | validation studies were performed using a validation | |
| | load with a total weight of 1.54 lbs. | load with a total weight of 3.97 lbs. | |
| Physical<br>Characteristic | Self-contained, stand-alone device | Self-contained, stand-alone device | Same |
| Design and<br>Construction | Welded frame onto which is mounted the<br>sterilization chamber along with a variety of<br>instruments and components, and controls, piping, all<br>of which is housed in covered frame as main<br>sterilizer.<br>The vacuum pump is housed in a frame with a cover<br>and configured separately, and connected to the main<br>sterilizer through a pumping pipe. | Welded frame onto which is mounted the sterilization<br>chamber along with a variety of instruments and<br>components, controls, piping, and vacuum pump, all<br>of which is housed in covered frame | Same Components as<br>Predicate with a<br>different configuration |
| Chamber Volume | 7 L | 14 L | Smaller than Predicate |
| Weight | Main sterilizer: 44.1 lbs (20 kg)<br>Pump module: 46.3 lbs (21 kg) | 147 lbs (67 kg) | Lighter than Predicate |
| Max Power | 1000 W | 1000 W | Same |
| Control System | Embedded Linux | Embedded Linux | Same |
| Internal process monitor | | | |
| Temperature | Chamber and vaporizer thermocouple | Chamber and vaporizer thermocouple | Same |
| Pressure | Chamber pressure transducers | Chamber pressure transducers | Same |
| Sterilant<br>Concentration | None | None | Same |
| Operational<br>Principle | Sterilization of the intended devices by exposure<br>under controlled conditions of pressure, temperature,<br>and time | Sterilization of the intended devices by exposure<br>under controlled conditions of pressure, temperature,<br>and time | Same |
| Operational<br>Parameters | Low pressure (vacuum; sub-atmospheric down to 3<br>Torr) and temperature (60°C) | Low pressure (vacuum; sub-atmospheric down to 3<br>Torr) and temperature (60°C) | Same |
| Pre-processing<br>Requirements | Cleaned, rinsed, and dried devices | Cleaned, rinsed, and dried devices | Same |
| | Subject Device | Predicate Device | Comparison |
| | Plasmapp Co., Ltd. | Plasmapp Co., Ltd. | Same |
| Devices | Reusable metal and non-metal medical devices that<br>are used in healthcare facilities, including those that<br>are sensitive to heat and moisture | Reusable metal and non-metal medical devices that<br>are used in healthcare facilities, including those that<br>are sensitive to heat and moisture | Same |
| Sterilization Cycles | One (1) pre-programmed; approximately 18 minutes…