(222 days)
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:
- STERPACK™ plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter
- 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,
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.
Based on the provided text, the device in question is the STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette, a vaporized hydrogen peroxide sterilizer. The acceptance criteria and the study proving the device meets these criteria are primarily focused on the non-clinical performance of the sterilizer, specifically its ability to sterilize medical devices. The information provided is typical of a 510(k) summary for a medical device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally "Pass" for compliance with various standards and guidance documents. The reported device performance is that it "Passes" these tests.
| Test Category | Standard/Guidance Document | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Human factors and usability engineering | 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 | Pass | Pass |
| Shelf-life test (Sterilant Preservation Test) | Manufacturer's internal standard | Pass | 1 year |
| Biocompatibility | ISO 10993-5:2009 | Pass | Pass |
| Software validation | IEC 62304:2006 + AMD1:2015; Guidance for Industry and Food and Drug Administration Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device", issued on May 11, 2005 | Pass | Pass |
| Electrical safety | EN 61010-1:2010; EN 61010-2-040:2015; IEC 60601-1:2005 (3rd Ed.) + CORR.1:2006 + CORR.2:2007 + A1:2012; EN 60601-1-2:2015 | Pass | Pass |
| RF disturbance | EN 55011:2009/A1:2010 | Pass | Pass |
| Electromagnetic compatibility (EMC) | EN 61326-1:2013; EN 61000-3-2:2014; EN 61000-3-3:2013; EN 60601-1-2:2015 | Pass | Pass |
| Resistance validation for biological indicator test | ISO 11138-1:2017 | Pass | Pass |
| Lumen sterilization | ISO 14937:2009 | Pass | Pass |
| Surface sterilization | ISO 14937:2009; ISO 11737-1:2018; ISO 11737-2:2009 | Pass | Pass |
| Mated surface sterilization | ISO 14937:2009; ISO 11737-1:2018; ISO 11737-2:2009 | Pass | Pass |
| Simulated use test | ASTM E1837-96:2014; ISO 11737-1:2018 | Pass | Pass |
| In-use test | ASTM E1837-96:2014 | Pass | Pass |
| Sporicidal activity test | AOAC 966.04 (AOAC 6.3.05:2013) | Pass | Pass |
| Bacteriostasis test | ISO 11737-1:2018 | Pass | Pass |
| Material compatibility test | ASTM D638; ASTM E8/E8M-16ae1; ASTM D790; ASTM E290-14; ASTM D256; ASTM E23-18; ASTM E1164; ASTM E313; ASTM D3985; ASTM F1249 | Pass | Pass |
| Delivery validation (Sterilizer) | ASTM D4169-14 | Pass | Pass |
| Delivery validation (Sterilant) | Manufacturer's internal standard | Pass | Pass |
| Hydrogen peroxide gas detection test | OSHA analytical method 1019 | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "sample size" in terms of number of medical devices or test runs for each individual performance test (e.g., lumen sterilization). Instead, it states for lumen sizes: "The validation testing for all lumen sizes was conducted using a maximum of five (5) lumens per load." It also mentions "a validation load with a total weight of 1 lb and 3.97 lbs with STERPACK™ plus and STERLOAD™, respectively."
- Sample Size for performance tests: For lumen sterilization, it mentions a maximum of five lumens per load. Other tests don't specify a detailed sample size breakdown within this document. The "Pass" results indicate that the testing met the minimum requirements for the specific standards.
- Data Provenance: The manufacturer is "Plasmapp Co., Ltd." in "Rep. of Korea (South Korea)." The document implies that the testing was conducted to meet the requirements of the U.S. FDA, but the location where the actual tests were performed is not explicitly stated. The nature of these tests (e.g., sterilization efficacy) strongly suggests they were performed as prospective validation studies to demonstrate the device's performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This type of information (number and qualifications of experts establishing ground truth for a test set) is generally relevant for AI/ML-driven diagnostic devices where human expert consensus forms the ground truth for image interpretation or diagnosis. For a sterilizer, the "ground truth" for its performance is typically established through objective, laboratory-based biological and physical testing using standardized methods and biological indicators (e.g., Geobacillus stearothermophilus). Therefore, the concept of "experts establishing ground truth for a test set" in the context of human interpretation of data is not applicable here. The "experts" would be the scientists and technicians conducting the validation tests according to the specified standards.
4. Adjudication Method for the Test Set
As the "ground truth" for a sterilizer's performance is objective (e.g., kill/no kill of microorganisms, meeting sensor specifications), adjudication methods like 2+1 or 3+1 (common in image interpretation studies) are not applicable. The device's performance is measured against established scientific and engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. MRMC studies are typically performed for diagnostic devices (especially those involving image interpretation) to evaluate the impact of a device (e.g., AI assistance) on human reader performance. This document is for a medical device sterilizer, which does not involve human interpretation of cases or AI assistance in that context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance tests described are standalone in the sense that they evaluate the sterilizer's ability to sterilize medical devices independently of human subjective assessment. The "algorithm" here is the sterilization cycle itself, and its effectiveness is measured directly through biological and chemical indicators. The results are based on the device's inherent design and operational parameters.
7. The Type of Ground Truth Used
The ground truth used for proving the sterilizer's efficacy is based on:
- Biological Activity: The ability to inactivate microorganisms (e.g., Geobacillus stearothermophilus spores) as measured by standard biological indicator tests (e.g., ISO 11138-1:2017, ISO 11737-1:2018, AOAC 966.04).
- Physical Parameters: Confirmation that the sterilizer operates within specified parameters (temperature, pressure, time) and that the sterilant is delivered effectively.
- Material Compatibility: Ensuring that the sterilization process does not degrade the materials of the medical devices being sterilized.
- Engineering Standards: Compliance with electrical safety, EMC, software validation, and other relevant engineering standards (e.g., IEC, EN, ASTM).
8. The Sample Size for the Training Set
This document does not refer to a "training set." The concept of training sets (and validation/test sets derived from them) is specific to machine learning or AI models that learn from data. This document is about a hardware device (sterilizer) whose performance is validated through defined physical and biological tests, not through training a model on a dataset.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the context of an AI/ML model for this device, this question is not applicable. The sterilizer's performance is established through controlled, laboratory-based validation studies against regulatory and industry standards for sterilization efficacy.
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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| 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: | Candace Cederman |
| Address: | CardioMed Device Consultants LLC1783 Forest DriveSuite 254Annapolis, MD 21401Tel: +1 410 674 2060 |
| 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 ClassificationName | Ethylene oxide gas sterilizer | Same |
| Classification ProductCode | MLR | Same |
| Regulation Number | 21 CFR 880.6860 | Same |
| Subject Device | Predicate Device | |
| Intended Use | The STERLINK™ FPS-15s Plus sterilizer is avaporized hydrogen peroxide sterilizerintended for use in the terminal sterilization ofcleaned, rinsed, and dried reusable metal andnonmetal medical devices used in healthcarefacilities. A pre-programmed sterilizationlumen cycle operates at low pressure and low | The STERLINK™ FPS-15s Plus sterilizerwith STERLOAD™ cassette is a vaporizedhydrogen peroxide sterilizer intended for usein the terminal sterilization of cleaned, rinsed,and dried reusable metal and nonmetalmedical devices used in healthcare facilities.A pre-programmed sterilization lumen cycleoperates at low pressure and low temperatureand is thus suitable for processing medicaldevices sensitive to heat and moisture.The STERLINK™ FPS-15s Plus cansterilize*:• Instruments with diffusion-restricted spacessuch as the hinged portion of forceps andscissors• Medical devices with a single stainless-steellumen with:o An inside diameter of 2.4 mm or larger anda length of 280 mm or shorter*The validation testing for all lumen sizes wasconducted using a maximum of five (5)lumens per load. Hospital loads should notexceed the maximum number of lumensvalidated by this testing. The validationstudies were performed using a validationload with a total weight of 3.97 lbs. |
| 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 |
| Chamber Volume | STERPACK™ plus :4.5 LSTERLOAD™: 14 L | STERLOAD™: 14 L |
| Weight | 147 lbs (67 kg) | Same |
| Max Power | 1000 W | Same |
| Control System | Embedded Linux | Same |
| Internal process monitor | ||
| Temperature | Chamber and vaporizer thermocouple | Same |
| Pressure | Chamber pressure transducers | Same |
| Sterilant Concentration | None | Same |
| Operational Principle | Sterilization of the intended devices byexposure under controlled conditions ofpressure, temperature, and time | Same |
| Subject Device | Predicate Device | |
| Devices | Reusable metal and non-metal medicaldevices that are used in healthcare facilities,including those that are sensitive to heatand moisture | Same |
| Sterilization Cycles | Two (2) pre-programmed cycles;STERPACK™ plus (approximately 14minutes) and STERLOAD™(approximately 36 minutes) | One (1) pre-programmed cycle;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 hydrogenperoxide | 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 | 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 usabilityengineering | Guidance for Industry and Food and Drug AdministrationStaff, "Appling Human Factors and Usability Engineeringto Medical Devices", issued on February 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 Drug AdministrationStaff, "Guidance for the Content of PremarketSubmissions for Software Contained in Medical 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 |
| 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 E1837-96:2014ISO 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 D638ASTM E8/E8M-16ae1ASTM D790ASTM E290-14ASTM D256ASTM E23-18ASTM E1164ASTM E313ASTM D3985ASTM 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.
§ 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).