STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette

K223015 · Plasmapp Co,., Ltd. · MLR · May 9, 2023 · General Hospital

Device Facts

• Record ID: K223015
• Device Name: STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
• Applicant: Plasmapp Co,., Ltd.
• Product Code: MLR · General Hospital
• Decision Date: May 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

The STERLINK™ FPS-15s Plus sterilizer 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™ FPS-15s 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 STERPACK™ plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter o STERLOAD™: 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 1 1b and 3.97 lbs with STERPACK™ plus and STERLOAD™, respectively.

Device Story

STERLINK™ FPS-15s Plus is a low-temperature, vaporized hydrogen peroxide sterilizer for healthcare facilities. It processes cleaned, rinsed, and dried reusable metal and nonmetal medical devices. The system uses unit-dose cassettes (STERPACK™ plus or STERLOAD™) containing 58-59.5% hydrogen peroxide. The device operates via a pre-programmed sterilization cycle using controlled pressure, temperature, and time to inactivate microorganisms. The 'pouch plus' mode uses a flexible chamber (STERPACK™ plus) for smaller volume sterilization. Operators place instruments in Tyvek® rolls before pouching. The system includes internal process monitors (thermocouples, pressure transducers) to ensure cycle parameters are met. Output is a sterilized medical device ready for clinical use. Benefits include effective sterilization of heat- and moisture-sensitive instruments, including those with diffusion-restricted spaces or lumens, without damaging device integrity.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via ISO 14937, ISO 11737-1/2, and ASTM E1837-96 standards. Testing confirmed sporicidal activity, lumen sterilization, mated surface sterilization, and material compatibility. Biocompatibility passed per ISO 10993-5. Electrical safety and EMC testing passed per EN 61010 and EN 60601 series.

Technological Characteristics

Stand-alone vaporized H2O2 sterilizer. Materials: Welded frame, Tyvek®/PET/LLDPE packaging. Sensing: Thermocouples (chamber/vaporizer), pressure transducers. Energy: 1000W max power. Connectivity: Embedded Linux control system. Sterilant: 58-59.5% aqueous H2O2 cassette. Dimensions: 147 lbs. Sterilization: Low-pressure/low-temperature vapor phase. Standards: ISO 14937, ISO 11737, ASTM E1837, EN 61010, EN 60601.

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices in healthcare facilities, including heat/moisture-sensitive instruments, hinged instruments, and single stainless-steel lumens (STERPACK™ plus: ≥1.6mm ID, ≤200mm length; STERLOAD™: ≥2.4mm ID, ≤280mm 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)

Submission Summary (Full Text)

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May 9, 2023

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

Re: K223015

Trade/Device Name: STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: April 7, 2023 Received: April 10, 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 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

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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. Dugard -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K223015

Device Name

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette

#### Indications for Use (Describe)

The STERLINK™ FPS-15s Plus sterilizer 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 preprogrammed sterilization lumen cycle operates at low pressure and is thus suitable for processing medical devices sensitive to heat and moisture.

The STERLINK™ FPS-15s 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 STERPACK™ plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter
- o STERLOAD™: 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 1 1b and 3.97 lbs with STERPACK™ plus and STERLOAD™, respectively,

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

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## 1. 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<br>Suite 254<br>Annapolis, MD 21401<br>Tel: [phone] |
| Preparation Date: | May 4, 2023 |

#### 2. Device Name and Code

| Device Trade Name: | STERLINKTM FPS-15s Plus sterilizer with STERPACKTM plus cassette |
|----------------------|------------------------------------------------------------------|
| Common Name: | Vapor Phase Hydrogen Peroxide Sterilization System |
| Classification Name: | Ethylene Oxide Gas Sterilizer |
| Product Code: | MLR |
| Regulation Number: | 880.6860 |
| Classification: | Class II |
| Review Panel: | General Hospital |

### 3. Device Description

The STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of medical devices and instruments.

This system consists of a main device and cassettes which are called the STERLINK™ FPS-15s Plus and STERPACK™ plus or STERLOAD™, respectively. The STERPACK™ plus and STERLOAD™ cassette contain 58-59.5% (weight concentration) of hydrogen peroxide (H2O2) which is utilized as the sterilant.

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The sterilization cycle with STERLOAD™ was cleared under K212200. The focus of this application is on the additional sterilization cycle with STERPACK™ plus.

### 4. Indications / Intended Use

The STERLINK™ FPS-15s Plus sterilizer 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™ FPS-15s 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: ●
- STERPACK™ plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or o shorter
- STERLOAD™: 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 1 1b and 3.97 lbs with STERPACK™ plus and STERLOAD™, respectively.

### 5. 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.

| | Subject Device | Predicate Device |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Plasmapp Co., Ltd. | Same |
| Base Sterilizer | FPS-15s Plus | Same |
| 510(k) Number | K223015 | K212200 |
| Device Classification<br>Name | Ethylene oxide gas sterilizer | Same |
| Classification Product<br>Code | MLR | Same |
| Regulation Number | 21 CFR 880.6860 | Same |
| | Subject Device | Predicate Device |
| Intended Use | The STERLINK™ FPS-15s Plus sterilizer is a<br>vaporized hydrogen peroxide sterilizer<br>intended for use in the terminal sterilization of<br>cleaned, rinsed, and dried reusable metal and<br>nonmetal medical devices used in healthcare<br>facilities. A pre-programmed sterilization<br>lumen cycle operates at low pressure and low<br> | The STERLINK™ FPS-15s Plus sterilizer<br>with STERLOAD™ cassette is a vaporized<br>hydrogen peroxide sterilizer intended for use<br>in the terminal sterilization of cleaned, rinsed,<br>and dried reusable metal and nonmetal<br>medical devices used in healthcare facilities.<br>A pre-programmed sterilization lumen cycle<br>operates at low pressure and low temperature<br>and is thus suitable for processing medical<br>devices sensitive to heat and moisture.<br><br>The STERLINK™ FPS-15s Plus can<br>sterilize*:<br>• Instruments with diffusion-restricted spaces<br>such as the hinged portion of forceps and<br>scissors<br>• Medical devices with a single stainless-steel<br>lumen with:<br>o An inside diameter of 2.4 mm or larger and<br>a length of 280 mm or shorter<br><br>*The validation testing for all lumen sizes was<br>conducted using a maximum of five (5)<br>lumens per load. Hospital loads should not<br>exceed the maximum number of lumens<br>validated by this testing. The validation<br>studies were performed using a validation<br>load with a total weight of 3.97 lbs. |
| Physical Characteristic | 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, controls,<br>piping, and vacuum pump, all of which is<br>housed in covered frame | Same |
| Chamber Volume | STERPACK™ plus :4.5 L<br>STERLOAD™: 14 L | STERLOAD™: 14 L |
| Weight | 147 lbs (67 kg) | Same |
| Max Power | 1000 W | Same |
| Control System | Embedded Linux | Same |
| <b>Internal process monitor</b> | | |
| Temperature | Chamber and vaporizer thermocouple | Same |
| Pressure | Chamber pressure transducers | Same |
| Sterilant Concentration | None | Same |
| Operational Principle | Sterilization of the intended devices by<br>exposure under controlled conditions of<br>pressure, temperature, and time | Same |
| | Subject Device | Predicate Device |
| Devices | Reusable metal and non-metal medical<br>devices that are used in healthcare facilities,<br>including those that are sensitive to heat<br>and moisture | Same |
| Sterilization Cycles | Two (2) pre-programmed cycles;<br>STERPACK™ plus (approximately 14<br>minutes) and STERLOAD™<br>(approximately 36 minutes) | One (1) pre-programmed cycle;<br>STERLOAD™ (approximately 36 minutes) |
| Sterilant | | |
| Model Name | STERPACK™ plus and STERLOAD™ | STERLOAD™ |
| Type | Cassette type (unit dose) | Same |
| Sterilant | 58-59.5% aqueous solution of hydrogen<br>peroxide | Same |
| Monitoring accessories | | |
| Biological Indicator | Self-contained biological indicator,<br>Geobacillus stearothermophilus | Same |
| Process Challenge<br>Device /<br>Routine Test Pack | Self-contained biological indicator,<br>Geobacillus stearothermophilus | Same |
| Chemical Indicator | Terragene® CI Strips and Tapes | Same |
| Miscellaneous (Sterilization wrap) | | |
| Load Packaging | Tyvek® and PET/LLDPE film | Same |

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## 510(k) Summary – K223015

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#### 510(k) Summary - K223015

Technological differences between the STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette and the predicate device are minimal and include:

- . The subject device includes an additional cycle, the STERPACK™ plus cycle (total two preprogrammed sterilization lumen cycles), versus one cycle for the predicate device.
- . The STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette has a smaller sterilization volume and sterilant quantity compared to the predicate device.
- . The sterilization chamber volume is smaller when the STERLINK™ FPS-15s Plus is utilized in pouch plus mode, as the sterilant only diffuses into the flexible chamber (i.e. pouch).
- . When using the pouch plus mode of the STERLINK™ FPS-15s Plus, the medical devices must first be placed in a Tyvek® roll and then placed into the STERPACK™ plus pouch, as the STERPACK™ plus pouch is not a sterile barrier.

The STERLINK™ FPS-15s Plus sterilizer performance and safety characteristics have been shown to provide a level of safety and efficacy at least equivalent to that of the predicate device.

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# 6. Performance Data

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

| Test | Standard/Guidance Document | Result |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Human factors and usability<br>engineering | Guidance for Industry and Food and Drug Administration<br>Staff, "Appling Human Factors and Usability Engineering<br>to Medical Devices", issued on February 3, 2016<br>IEC 62366-1:2015 | Pass |
| Shelf-life test<br>(Sterilant Preservation Test) | Manufacturer's internal standard | 1 year |
| Biocompatibility | ISO 10993-5:2009 | Pass |
| Software validation | IEC 62304:2006 + AMD1:2015<br>Guidance for Industry and Food and Drug Administration<br>Staff, "Guidance for the Content of Premarket<br>Submissions for Software Contained in Medical Device",<br>issued on May 11, 2005 | Pass |
| Electrical safety | EN 61010-1:2010<br>EN 61010-2-040:2015<br>IEC 60601-1:2005 (3rd Ed.) + CORR.1:2006 +<br>CORR.2:2007 + A1:2012<br>EN 60601-1-2:2015 | Pass |
| RF disturbance | EN 55011:2009/A1:2010 | Pass |
| Electromagnetic compatibility (EMC) | EN 61326-1:2013<br>EN 61000-3-2:2014<br>EN 61000-3-3:2013<br>EN 60601-1-2:2015 | Pass |
| Resistance validation for biological<br>indicator test | ISO 11138-1:2017 | Pass |
| Lumen sterilization | ISO 14937:2009 | Pass |
| Surface sterilization | ISO 14937:2009<br>ISO 11737-1:2018<br>ISO 11737-2:2009 | Pass |
| Mated surface sterilization | ISO 14937:2009<br>ISO 11737-1:2018<br>ISO 11737-2:2009 | Pass |
| Simulated use test | ASTM E1837-96:2014<br>ISO 11737-1:2018 | Pass |
| In-use test | ASTM E1837-96:2014 | Pass |
| Sporicidal activity test | AOAC 966.04 (AOAC 6.3.05:2013) | Pass |
| Bacteriostasis test | ISO 11737-1:2018 | Pass |
| Test | Standard/Guidance Document | Result |
| Material compatibility test | ASTM D638<br>ASTM E8/E8M-16ae1<br>ASTM D790<br>ASTM E290-14<br>ASTM D256<br>ASTM E23-18<br>ASTM E1164<br>ASTM E313<br>ASTM D3985<br>ASTM F1249 | Pass |
| Delivery validation (Sterilizer) | ASTM D4169-14 | Pass |
| Delivery validation (Sterilant) | Manufacturer's internal standard | Pass |
| Hydrogen peroxide gas detection test | OSHA analytical method 1019 | Pass |

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### 510(k) Summary – K223015

## 7. Conclusions

The conclusions drawn from the nonclinical testing demonstrate that the device in 510(k) K223015, the STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette, is as safe, as effective, and performs as well, or better, than the legally marketed predicate device cleared under K212200.