STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

K231169 · Plasmapp Co,., Ltd. · MLR · May 25, 2023 · General Hospital

Device Facts

• Record ID: K231169
• Device Name: STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI 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: May 25, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

The STERLINK plus sterilizer with STERLOAD cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal 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 plus 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 2.4 mm or larger and a length of 280 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 3 .97 lbs.

Device Story

Low-temperature vaporized hydrogen peroxide sterilizer; uses STERLOAD cassette (58-59.5% H2O2) as sterilant. System comprises main device, pump module, and cassette. Operates via pre-programmed sterilization cycle (approx. 36 mins) at sub-atmospheric pressure (down to 3 Torr). Used in healthcare facilities by trained personnel. Input: cleaned, rinsed, dried reusable metal/non-metal medical devices. Output: terminally sterilized devices. Includes monitoring accessories: self-contained biological indicators (SCBI) and chemical indicators (strips/tapes) to verify cycle efficacy. Healthcare providers use indicators to confirm sterilization conditions met before device release. Benefits: enables safe, fast, reliable sterilization of heat/moisture-sensitive instruments.

Clinical Evidence

No clinical data. Evidence based on non-clinical bench testing including risk management (ISO 14971), biocompatibility (ISO 10993-5), electrical safety (IEC 60601-1/61010-1), EMC (IEC 60601-1-2), and sterilization validation (ISO 14937, ISO 11138, ISO 11737, ASTM E1837).

Technological Characteristics

Welded frame construction; 14L chamber volume; 1000W max power. Uses 59% aqueous H2O2. Sensing via chamber/vaporizer thermocouples and pressure transducers. Connectivity: Embedded Linux control system. Sterilization: Low-pressure vaporized H2O2. Packaging: Tyvek/PET/LLDPE film. Software: IEC 62304 compliant.

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried reusable metal medical devices in healthcare facilities, including heat/moisture-sensitive instruments with diffusion-restricted spaces (e.g., hinged forceps/scissors) and single stainless steel lumens (≥2.4 mm ID, ≤280 mm length).

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 Sterilizer with STERLOAD™ Cassette (K212200)
• Tyvek® Roll with CI for STERLINK™ Sterilizer (K212198)
• Terragene Bionova® SCBI (BT96), Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye® (CD42), Terragene Cintape® (CT40) (K212193)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 25, 2023

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

Re: K231169

Trade/Device Name: STERLINK™ plus Sterilizer with STERLOAD™ Cassette, Tyvek Roll with CI 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: April 24, 2023 Received: April 25, 2023

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.

-2

# Christopher K. Dugard

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) K231169

Device Name STERLINK Plus Sterilizer with STERLOAD Cassette

Indications for Use (Describe)

The STERLINK Plus sterilizer with STERLOAD cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal 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 Plus 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 2.4 mm or larger and a length of 280 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 3 .97 lbs.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="checked" type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</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) K231169

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 compatibility for use in the Tyvek® Roll with CI for STERLINK Sterilizer, when used in CHAMBER mode, are as follows: Aluminum 6061, Stainless Steel 304, Stainless Steel 316L, Titanium, Acrylonitrile Butadiene Styrene (ABS), High Density Polyethylene (HPDE), Polypropylene (PP), Polytetrafluorethylene (PTFE) and Silicone (Hardness 50).

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

- · 3.97 pounds (1.8kg) for CHAMBER mode of FPS-15s Plus
- 3.97 pounds (1.8kg) for CHAMBER mode of STERLINK plus sterilizer
- 1.54 pounds (0.7kg) 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) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | X |

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) K231169

### Device Name

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

Indications for Use (Describe)

Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 10^6 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 sterlization 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 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."

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510(k) Summary for K231169 [as required by 21 CFR 807.92(c)]

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

# 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: | May 22, 2023 |

# Device Name and Code

| Device Trade Name: | A. STERLINK plus Sterilizer with STERLOADTM Cassette<br>B. Tyvek® Roll with CI for STERLINKTM Sterilizer<br>C. Terragene Bionova SCBI (BT96), Terragene Bionova Reader<br>Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye<br>(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 |
| Predicate Device: | STERLINK FPS-15s Plus Sterilizer with STERLOAD™ Cassette<br>(K212200)<br>Tyvek® Roll with CI for STERLINK™ Sterilizer (K212198)<br>Terragene Bionova® SCBI (BT96), Terragene Bionova® Reader<br>Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye® (CD42),<br>Terragene Cintape® (CT40) - (K212193) |

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

#### Device Description A.1

The STERLINK plus sterilizer with STERLOAD™ 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 plus and STERLOAD™ cassette, respectively. The STERLOAD™ cassette contains 58-59.5% (weight concentration) of hydrogen peroxide (HzO2) which is utilized as the sterilant.

#### Indications / Intended Use A.2

The Intended use of the subject device is identical to that of the predicate device cleared under K212200.

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The STERLINK plus 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: ●
- An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter O

* 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 3.97 lbs.

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

The STERLINK plus sterilizer is substantially equivalent to the following legally marketed predicate device.

| | Subject Device | Predicate Device | Substantially<br>Equivalent<br>or Difference |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Device Name<br>(Model) | STERLINK plus Sterilizer<br>with STERLOAD™ Cassette | FPS-15s Plus Sterilizer with<br>STERLOAD™ Cassette | |
| 510(k) Number | - | K212200 | |
| Product Code | MLR | MLR | Identical |
| Intended Use | The STERLINK plus sterilizer<br>with STERLOAD™ cassette is<br>a vaporized hydrogen peroxide<br>sterilizer intended for use in the<br>terminal sterilization of cleaned,<br>rinsed, and dried reusable metal<br>and nonmetal medical devices<br>used in healthcare facilities.<br><br>A pre-programmed sterilization<br>lumen cycle operates at low<br>pressure and low temperature<br>and is thus suitable for<br>processing medical devices<br>sensitive to heat and moisture.<br><br>The STERLINK plus can<br>sterilize*:<br>• Instruments with diffusion-<br>restricted spaces such as the<br>hinged portion of forceps and<br>scissors<br>• Medical devices with a single<br>stainless-steel lumen with: | The STERLINK™ FPS-15s Plus<br>sterilizer with STERLOAD™<br>cassette is a vaporized hydrogen<br>peroxide sterilizer intended for use<br>in the terminal sterilization of<br>cleaned, rinsed, and dried reusable<br>metal and nonmetal medical<br>devices used in healthcare facilities.<br><br>A pre-programmed sterilization<br>lumen cycle operates at low<br>pressure and low temperature and is<br>thus suitable for processing medical<br>devices sensitive to heat and<br>moisture.<br><br>The STERLINK™ FPS-15s Plus<br>can sterilize*:<br>• Instruments with diffusion-<br>restricted spaces such as the<br>hinged portion of forceps and<br>scissors<br>• Medical devices with a single<br>stainless-steel lumen with: | Identical |
| | Subject Device | Predicate Device | Substantially<br>Equivalent<br>or Difference |
| Device Name<br>(Model) | STERLINK plus Sterilizer<br>with STERLOADTM Cassette | FPS-15s Plus Sterilizer with<br>STERLOADTM Cassette | |
| | - An inside diameter of 2.4 m<br>m or larger and a length of<br>280 mm or shorter | - An inside diameter of 2.4 mm or<br>larger and a length of 280 mm<br>or shorter | |
| | *The validation testing for all<br>lumen sizes was conducted<br>using a maximum of five (5)<br>lumens per load. Hospital loads<br>should not exceed the maximum<br>number of lumens validated by<br>this testing. The validation<br>studies were performed using a<br>validation load with a total<br>weight of 3.97 lbs. | *The validation testing for all<br>lumen sizes was conducted using a<br>maximum of five (5) lumens per<br>load. Hospital loads should not<br>exceed the maximum number of<br>lumens validated by this testing.<br>The validation studies were<br>performed using a validation load<br>with a total weight of 3.97 lbs. | |
| Physical<br>Characteristic | Self-contained, stand-alone<br>device | Self-contained, stand-alone device | Identical |
| Design and<br>Construction | Welded frame onto which is<br>mounted the sterilization<br>chamber along with a variety of<br>instruments and components,<br>controls, piping, and vacuum<br>pump, all of which is housed in<br>covered frame | Welded frame onto which is<br>mounted the sterilization chamber<br>along with a variety of instruments<br>and components, controls, piping,<br>and vacuum pump, all of which is<br>housed in covered frame | Identical |
| Chamber Volume | 14 L | 14 L | Identical |
| Max Power | 1000 W | 1000 W | Identical |
| Weight | 128 lbs. (58kg) | 128 lbs. (58kg) | Identical |
| Control system | Embedded Linux | Embedded Linux | Identical |
| Software | IEC 62304 | IEC 62304 | Identical |
| Electrical Safety | IEC 60601-1<br>IEC 61010-1 | IEC 60601-1<br>IEC 61010-1 | Identical |
| Electromagnetic<br>Compatibility<br>(EMC) | IEC 60101-1-2 | IEC 60101-1-2 | Identical |
| Labeling | STERLINK plus product label,<br>User manual | FPS-15s Plus product label, User<br>manual | Differ only in<br>name |
| | Internal Process Monitor | | |
| Temperature | Chamber and vaporizer<br>thermocouple | Chamber and vaporizer<br>thermocouple | Identical |
| Pressure | Chamber pressure transducers | Chamber pressure transducers | Identical |
| Operational<br>Principle | Sterilization of the intended<br>devices by exposure under<br>controlled conditions of<br>pressure, temperature, and time | Sterilization of the intended devices<br>by exposure under controlled<br>conditions of<br>pressure, temperature, and time | Identical |
| | Low pressure (vacuum; sub-<br>atmospheric down to 3 Torr) | Low pressure (vacuum; sub-<br>atmospheric down to 3 Torr) | Identical |
| | Subject Device | Predicate Device | Substantially<br>Equivalent<br>or Difference |
| Device Name<br>(Model) | STERLINK plus Sterilizer<br>with STERLOAD™ Cassette | FPS-15s Plus Sterilizer with<br>STERLOAD™ Cassette | Identical |
| Pre-processing<br>Requirements | Cleaned, rinsed, and dried<br>devices | Cleaned, rinsed, and dried devices | Identical |
| Devices | Reusable metal and non-metal<br>medical devices that are used in<br>healthcare facilities, including<br>those that are sensitive to heat<br>and moisture | Reusable metal and non-metal<br>medical devices that are used in<br>healthcare facilities, including those<br>that are sensitive to heat and<br>moisture | Identical |
| Sterilization<br>Cycles | One (1) pre-programmed;<br>approximately 36 minutes | One (1) pre-programmed;<br>approximately 36 minutes | Identical |
| | Sterilant | | |
| Model Name | STERLOAD™ | STERLOAD™ | Identical |
| Type | Cassette type (unit dose) | Cassette type (unit dose) | Identical |
| Sterilant | 59% aqueous solution of<br>hydrogen peroxide | 59% aqueous solution of hydrogen<br>peroxide | Identical |
| | Monitoring Accessories | | |
| Biological<br>Indicator | Self-contained biological<br>indicator,<br>Geobacillus stearothermophilus | Self-contained biological indicator,<br>Geobacillus stearothermophilus | Identical |
| Process Challenge<br>Device /<br>Routine Test Pack | Self-contained biological<br>indicator,<br>Geobacillus stearothermophilus | Self-contained biological indicator,<br>Geobacillus stearothermophilus | Identical |
| Chemical<br>Indicator | Terragene® CI Strips and Tapes | Terragene® CI Strips and Tapes | Identical |
| | Miscellaneous (Sterilization wrap) | | |
| Load Packaging | Tyvek® and PET/LLDPE film | Tyvek®/HDPE pouches | Substantially<br>Equivalent |

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No technological differences exist between the subject and predicate devices. The two devices differ only in name.

#### Performance Data A.4

Non-clinical tests were performed on the predicate using the following standards and/or guidance documents:

| Test | Standard/Guidance Document | Result |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Risk management | ISO 14971 | |
| Human factors and usability<br>engineering | Guidance for Industry and Food and Drug<br>Admi…