(100 days)
The STERLINK™ FPS-15s 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™ 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 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.
The STERLINK™ FPS-15s 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 and cassette which are called the STERLINK™ and STERLOAD™, respectively. The STERLOAD™ cassette contains 59% (weight concentration) of hydrogen peroxide (H2O2) which is utilized as the sterilant.
Here's a breakdown of the acceptance criteria and study information for the STERLINK™ FPS-15s Plus Sterilizer with STERLOAD™ Cassette, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For medical device sterilization submissions, the acceptance criteria are generally defined by adherence to recognized national and international standards. The "Reported Device Performance" in this context is the statement of "Pass" for each test, indicating that the device met the requirements of the specified standard.
| Test Category | Standard/Guidance Document | Acceptance Criteria (Defined by Standard) | Reported Device Performance |
|---|---|---|---|
| Safety & Effectiveness (General) | ISO 14971:2012 (Risk management) | Adherence to risk management principles | Pass |
| Guidance for Industry and Food and Drug Administration Staff, "Appling Human Factors and Usability Engineering to Medical Devices", issued on February 3, 2016; IEC 62366-1:2015 (Human factors and usability engineering) | Compliance with human factors principles | Pass | |
| ISO 10993-5:2009 (Biocompatibility) | Non-cytotoxicity | Pass | |
| IEC 62304:2006 + AMD1:2015; "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device", issued on May 11, 2005 (Software validation) | Software functions correctly and safely | Pass | |
| EN 61010-1:2010; EN 61010-2-040:2015; IEC 60601-1:2005 (3rd Ed.) + CORR.1:2006 + CORR.2:2007 + A1:2012 (Electrical safety) | Electrical safety standards met | Pass | |
| EN 55011:2009/A1:2010 (RF disturbance) | RF emission limits met | Pass | |
| EN 61326-1:2013; EN 61000-3-2:2014; EN 61000-3-3:2013; EN 60601-1-2:2015 (Electromagnetic compatibility (EMC)) | EMC standards met | Pass | |
| OSHA analytical method 1019 (Hydrogen peroxide gas detection test) | H2O2 levels within safe limits | Pass | |
| Sterilization Efficacy | ISO 11138-1:2017 (Resistance validation for biological indicator test) | Biological indicator resistance verified | Pass |
| ISO 14937:2009 (Lumen sterilization) | Sterility Assurance Level (SAL) met for lumens | Pass | |
| ISO 14937:2009; ISO 11737-1:2018; ISO 11737-2:2009 (Surface sterilization) | SAL met for surfaces | Pass | |
| ISO 14937:2009; ISO 11737-1:2018; ISO 11737-2:2009 (Mated surface sterilization) | SAL met for mated surfaces | Pass | |
| AOAC 966.04 (Sporicidal activity test) | Demonstrated sporicidal efficacy | Pass | |
| ISO 11737-1:2018 (Bacteriostasis test) | No inhibition of microbial growth | Pass | |
| Device Performance & Durability | Manufacturer's internal standard (Shelf-life test (Sterilant Preservation Test)) | Sterilant remains viable for 1 year | 1 year |
| ASTM E1837-96(2014); ISO 11737-1:2018 (Simulated use test) | Effective under simulated use conditions | Pass | |
| ASTM E1837-96(2014) (In-use test) | Effective under actual use conditions | Pass | |
| ASTM D638; ASTM E8/E8M-16ae1; ASTM D790; ASTM E290-14; ASTM D256; ASTM E23-18; ASTM E1164; ASTM E313; ASTM D3985; ASTM F1249 (Material compatibility test) | Materials maintain integrity | Pass | |
| ASTM D4169-14 (Delivery validation) | Sterilant delivery is consistent | Pass |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of "samples" in a general sense for each test. However, it does provide some details related to test conditions:
- Lumen Sterilization: Validation testing for lumen sizes was conducted using a maximum of five (5) lumens per load.
- Validation Studies (General): Validation studies were performed using a validation load with a total weight of 3.97 lbs.
- Data Provenance: The document generally refers to "non-clinical tests" performed using listed standards. There is no specific mention of country of origin for the data or whether the studies were retrospective or prospective. Given the nature of device validation, these tests are typically performed in a laboratory setting as prospective experiments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts) is generally not applicable to the validation of a sterilization device. The "ground truth" for sterilization efficacy is established through standardized microbiological testing using biological indicators and adherence to defined Sterility Assurance Levels (SALs). These are objective biological endpoints, not subjective expert interpretations.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. The results are typically objective (e.g., growth or no growth of biological indicators, direct measurements of physical parameters) and do not require expert adjudication in the same way clinical image interpretation might.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a sterilization device, not an AI-powered diagnostic tool that relies on human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical sterilizer and sterilant system, not an algorithm. Its performance is inherent to its design and chemical process, independent of human real-time interaction beyond operation.
7. The Type of Ground Truth Used
The ground truth used for sterilization efficacy is primarily microbiological endpoints, specifically:
- Sterility Assurance Level (SAL): Demonstrated by the inactivation of biological indicators (Geobacillus stearothermophilus) to a specified probability (e.g., 10^-6), as required by standards like ISO 14937.
- Sporicidal activity: Confirmed through tests like AOAC 966.04.
- Material compatibility: Assessed through various ASTM and ISO standards to ensure the device does not damage materials or leave harmful residues.
- Physical and Chemical Parameters: The ground truth for operational aspects (temperature, pressure, sterilant concentration, shelf-life, etc.) is based on established scientific principles and measured values.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set." Its validation involves traditional engineering, chemistry, and microbiology testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 22, 2021
Plasmapp Co.,Ltd % Candace Cederman Consultant CardioMed Device Consultants LLC 1783 Forest Drive. Suite 254 Annapolis, Maryland 21401
Re: K212200
Trade/Device Name: STERLINKTM FPS-15s Plus, STERLOAD™ Cassette Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene oxide gas sterilizer Regulatory Class: Class II Product Code: MLR Dated: September 20, 2021 Received: September 21, 2021
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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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) K212200
Device Name
STERLINKTM FPS-15s Plus Sterilizer with STERLOAD™ Cassette
Indications for Use (Describe)
The STERLINK™ FPS-15s 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™ 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 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | --------------------------------------------- |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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1. General Information
| Applicant/Submitter: | Plasmapp Co., Ltd.BVC-111, 125, Gwahak-ro,Yuseong-gu, Daejeon, 34141,Rep. of Korea (South Korea)Tel: +82 (0)42 716 2115 |
|---|---|
| Contact Person:Address: | Candace CedermanCardioMed Device Consultants LLC1783 Forest DriveSuite 254Annapolis, MD 21401Tel: +1 410 674 2060 |
| Preparation Date: | October 12, 2021 |
2. Device Name and Code
| Device Trade Name: | STERLINK™ FPS-15s Plus Sterilizer with STERLOAD™ 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 STERLOAD™ cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of
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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 and cassette which are called the STERLINK™ and STERLOAD™, respectively. The STERLOAD™ cassette contains 59% (weight concentration) of hydrogen peroxide (H2O2) which is utilized as the sterilant.
4. Indications / Intended Use
The STERLINK™ FPS-15s 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 and nonmetal medical devices used in healthcare facilities. A pre-programmed 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 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.
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 | |
|---|---|---|
| Plasmapp Co., Ltd. | Sterilucent, Inc. | |
| Device Name | FPS-15s Plus | PSD-85 |
| 510(k) Number | K212200 | K140464 |
| Device ClassificationName | Ethylene oxide gas sterilizer | Same |
| Classification ProductCode | MLR | Same |
| Regulation Number | 21 CFR 880.6860 | Same |
| Subject Device | Predicate Device | |
| Plasmapp Co., Ltd. | Sterilucent, Inc. | |
| Intended Use | The STERLINKTM FPS-15s Plus sterilizerwith STERLOADTM cassette is a vaporizedhydrogen peroxide sterilizer intended for usein the terminal sterilization of cleaned,rinsed, and dried reusable metal andnonmetal medical devices used in healthcarefacilities. A pre-programmed sterilization | The PSD-85 is a vaporized hydrogenperoxide sterilizer intended for use in theterminal sterilization of cleaned, rinsed anddried reusable metal and nonmetal medicaldevices used in healthcare facilities.The two pre-programmed sterilizationcycles, the Lumen and the Non-LumenCycles, operate at low pressure and lowtemperature and are thus suitable forprocessing medical devices sensitive to heatand moisture.The PSD-85 Lumen Cycle can sterilize*:• Instruments with diffusion-restrictedspaces such as the hinged portion of forcepsand scissors• Medical devices with a single stainless steellumen with:o An inside diameter of 1 mm or larger anda length of 60 mm or shortero An inside diameter of 2 mm or larger anda length of 250 mm or shortero An inside diameter of 3 mm or larger anda length of 350 mm or shorterThe validation testing for all lumen sizeswas conducted using a maximum of ten (10)lumens per load. Hospital loads should notexceed the maximum number of lumensvalidated by this testing. The validationstudies were performed using a validationload consisting of one instrument tray with atotal weight of 10.4 lbs.The PSD-85 Non-Lumen Cycle cansterilize*:• Non-lumen instruments including non-lumen instruments with stainless steeldiffusion-restricted areas such as the hingedportion of forceps or scissors.**The validation studies were conductedusing a validation load consisting of oneinstrument tray with a total weight of 25.3lbs. |
| Physical Characteristic | Self-contained, stand-alone device | Same |
| Design andConstruction | Welded frame onto which is mounted thesterilization chamber along with a variety ofinstruments and components, controls,piping, and vacuum pump, all of which ishoused in covered frame | Same |
| Subject Device | Predicate Device | |
| Plasmapp Co., Ltd. | Sterilucent, Inc. | |
| Chamber Volume | 14 L | 85 L |
| Weight | 147 lbs (67 kg) | 440 lbs (200 kg) |
| Max Power | 1000 W | 1650 W |
| Control System | Embedded Linux | Atmel AT91SAM7 Microprocessor |
| Internal process monitor | ||
| Temperature | Chamber and vaporizer thermocouple | Chamber and vaporizer thermistors |
| Pressure | Chamber pressure transducers | Same |
| Sterilant Concentration | None | Real-time hydrogen peroxide vapor monitor |
| Operational Principle | Sterilization of the intended devices byexposure under controlled conditions ofpressure, temperature, and time | Same |
| OperationalParameters | Low pressure (vacuum; sub-atmosphericdown to 3 Torr) and temperature (60°C) | Low pressure (vacuum; sub-atmosphericdown to 0.4 Torr) and temperature (55°C) |
| Pre-processingRequirements | Cleaned, rinsed, and dried devices | Same |
| Devices | Reusable metal and non-metal medicaldevices that are used in healthcare facilities,including those that are sensitive to heat andmoisture | Same |
| Sterilization Cycles | One (1) pre-programmed; approximately 36minutes | Two (2) pre-programmed;Lumen (approximately 72 minutes) andNon-Lumen (approximately 40 minutes) |
| Sterilant | ||
| Model Name | STERLOAD™ | Sterilant Disc |
| Type | Cassette type (unit dose) | Disk type |
| Sterilant | 59% aqueous solution of hydrogen peroxide | Same |
| Monitoring accessories | ||
| Biological Indicator | Self-contained biological indicator,Geobacillus stearothermophilus | Same |
| Process ChallengeDevice /Routine Test Pack | Self-contained biological indicator,Geobacillus stearothermophilus | Same |
| Chemical Indicator | Terragene® CI Strips and Tapes | Sterilucent CI Strips, Labels and Tape |
| Miscellaneous (Sterilization wrap) | ||
| Load Packaging | Tyvek®/HDPE pouches | Tyvek®/Mylar pouches, trays wrapped withpolypropylene sterilization wrap, rigid containers |
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STERLINK™ FPS-15s Plus Sterilizer with STERLOAD™ Cassette 510(k) Summary – K212200
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Technological differences between the STERLINK™ FPS-15s Plus sterilizer and the predicate device are minimal and include:
- The STERLINK™ FPS-15s Plus sterilizer has a smaller sterilization chamber volume, ● is lighter, and requires less maximum power compared to the predicate device.
- The STERLINK™ FPS-15s Plus sterilizer has one pre-programmed sterilization . lumen cycle, versus two cycles for the predicate device.
- The STERLINK™ FPS-15s Plus sterilizer utilizes unit dose sterilant cassettes versus ● sterilant disks for the predicate device.
- . The STERLINK™ FPS-15s Plus sterilizer utilizes a fixed dose of sterilant, versus a variable dose of sterilant based on real time measured and monitored hydrogen peroxide vapor concentration for the predicate device.
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.
6. Performance Data
Non-clinical tests were performed using the following standards and/or guidance documents:
| Test | Standard/Guidance Document | Result |
|---|---|---|
| Risk management | ISO 14971:2012 | Pass |
| Human factors and usabilityengineering | Guidance for Industry and Food and DrugAdministration Staff, "Appling Human Factors andUsability Engineering to Medical Devices", issued onFebruary 3, 2016IEC 62366-1:2015 | Pass |
| Shelf-life test(Sterilant Preservation Test) | Manufacturer's internal standard | 1 year |
| Biocompatibility | ISO 10993-5:2009 | Pass |
| Software validation | IEC 62304:2006 + AMD1:2015Guidance for Industry and Food and DrugAdministration Staff, "Guidance for the Content ofPremarket Submissions for Software Contained inMedical Device", issued on May 11, 2005 | Pass |
| Electrical safety | EN 61010-1:2010EN 61010-2-040:2015IEC 60601-1:2005 (3rd Ed.) + CORR.1:2006 +CORR.2:2007 + A1:2012EN 60601-1-2:2015 | Pass |
| RF disturbance | EN 55011:2009/A1:2010 | Pass |
| Electromagnetic compatibility(EMC) | EN 61326-1:2013EN 61000-3-2:2014EN 61000-3-3:2013EN 60601-1-2:2015 | Pass |
| Resistance validation for biologicalindicator test | ISO 11138-1:2017 | Pass |
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| STERLINK™ FPS-15s Plus Sterilizer with STERLOAD™ Cassette |
|---|
| 510(k) Summary - K212200 |
| Test | Standard/Guidance Document | Result |
|---|---|---|
| Lumen sterilization | ISO 14937:2009 | Pass |
| Surface sterilization | ISO 14937:2009ISO 11737-1:2018ISO 11737-2:2009 | Pass |
| Mated surface sterilization | ISO 14937:2009ISO 11737-1:2018ISO 11737-2:2009 | Pass |
| Simulated use test | ASTM E1837-96(2014)ISO 11737-1:2018 | Pass |
| In-use test | ASTM E1837-96(2014) | Pass |
| Sporicidal activity test | AOAC 966.04 | Pass |
| Bacteriostasis test | ISO 11737-1:2018 | Pass |
| Material compatibility test | ASTM D638ASTM E8/E8M-16ae1ASTM D790ASTM E290-14ASTM D256ASTM E23-18ASTM E1164ASTM E313ASTM D3985ASTM F1249 | Pass |
| Delivery validation | ASTM D4169-14 | Pass |
| Hydrogen peroxide gas detectiontest | OSHA analytical method 1019 | Pass |
7. Conclusions
The conclusions drawn from the nonclinical tests demonstrates that the device in 510(k) K212200, STERLINK™ FPS-15s Plus Sterilizer with STERLOAD™ Cassette, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K140464.
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
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.(b)
Classification. Class II (performance standards).