(100 days)
Not Found
No
The summary describes a vaporized hydrogen peroxide sterilizer and its sterilization process. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the chemical sterilization method and its validation.
No
This device is a sterilizer intended for the sterilization of reusable medical devices, not for diagnosing, treating, or preventing disease in a patient.
No
This device is a sterilizer intended for the terminal sterilization of medical devices, not for diagnosing medical conditions.
No
The device description clearly outlines a physical sterilizer system consisting of a main device and a cassette containing hydrogen peroxide, indicating it is a hardware-based medical device. While it mentions software validation in the performance studies, the core function and components are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "terminal sterilization of cleaned, rinsed, and dried reusable metal medical devices used in healthcare facilities." This is a process performed on medical devices themselves, not on biological samples from a patient for diagnostic purposes.
- Device Description: The device description details a sterilizer that uses vaporized hydrogen peroxide to inactivate microorganisms on medical devices. This aligns with sterilization, not in vitro diagnostics.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Using reagents or assays to detect specific substances in samples
The device is a sterilizer, which is a type of medical device used to prepare other medical devices for use. It does not perform diagnostic testing.
N/A
Intended Use / Indications for 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 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:
- 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.
Product codes (comma separated list FDA assigned to the subject device)
MLR
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed.
- Risk management (ISO 14971:2012) - Pass
- 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
- Shelf-life test (Sterilant Preservation Test) (Manufacturer's internal standard) - 1 year
- Biocompatibility (ISO 10993-5:2009) - 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
- 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
- RF disturbance (EN 55011:2009/A1:2010) - Pass
- Electromagnetic compatibility (EMC) (EN 61326-1:2013; EN 61000-3-2:2014; EN 61000-3-3:2013; EN 60601-1-2:2015) - Pass
- Resistance validation for biological indicator test (ISO 11138-1:2017) - Pass
- Lumen sterilization (ISO 14937:2009) - Pass
- Surface sterilization (ISO 14937:2009; ISO 11737-1:2018; ISO 11737-2:2009) - Pass
- Mated surface sterilization (ISO 14937:2009; ISO 11737-1:2018; ISO 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 D638; ASTM E8/E8M-16ae1; ASTM D790; ASTM E290-14; ASTM D256; ASTM E23-18; ASTM E1164; ASTM E313; ASTM D3985; ASTM F1249) - Pass
- Delivery validation (ASTM D4169-14) - Pass
- Hydrogen peroxide gas detection test (OSHA analytical method 1019) - Pass
The conclusions drawn from the nonclinical tests demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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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3
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 Cederman
CardioMed Device Consultants LLC
1783 Forest Drive
Suite 254
Annapolis, MD 21401
Tel: +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
4
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 Classification | ||
| Name | Ethylene oxide gas sterilizer | Same |
| Classification Product | ||
| Code | 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 sterilizer | |
| with STERLOADTM 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 | ||
| The PSD-85 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. | ||
| The two pre-programmed sterilization | ||
| cycles, the Lumen and the Non-Lumen | ||
| Cycles, operate at low pressure and low | ||
| temperature and are thus suitable for | ||
| processing medical devices sensitive to heat | ||
| and moisture. |
The PSD-85 Lumen Cycle can sterilize*:
• Instruments with diffusion-restricted
spaces such as the hinged portion of forceps
and scissors
• Medical devices with a single stainless steel
lumen with:
o An inside diameter of 1 mm or larger and
a length of 60 mm or shorter
o An inside diameter of 2 mm or larger and
a length of 250 mm or shorter
o An inside diameter of 3 mm or larger and
a length of 350 mm or shorter
*The validation testing for all lumen sizes
was conducted using a maximum of ten (10)
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 consisting of one instrument tray with a
total weight of 10.4 lbs.
The PSD-85 Non-Lumen Cycle can
sterilize**:
• Non-lumen instruments including non-
lumen instruments with stainless steel
diffusion-restricted areas such as the hinged
portion of forceps or scissors.
**The validation studies were conducted
using a validation load consisting of one
instrument tray with a total weight of 25.3
lbs. |
| Physical Characteristic | Self-contained, stand-alone device | Same |
| Design and
Construction | Welded frame onto which is mounted the
sterilization chamber along with a variety of
instruments and components, controls,
piping, and vacuum pump, all of which is
housed 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 by
exposure under controlled conditions of
pressure, temperature, and time | Same |
| Operational
Parameters | Low pressure (vacuum; sub-atmospheric
down to 3 Torr) and temperature (60°C) | Low pressure (vacuum; sub-atmospheric
down to 0.4 Torr) and temperature (55°C) |
| Pre-processing
Requirements | Cleaned, rinsed, and dried devices | Same |
| Devices | Reusable metal and non-metal medical
devices that are used in healthcare facilities,
including those that are sensitive to heat and
moisture | Same |
| Sterilization Cycles | One (1) pre-programmed; approximately 36
minutes | Two (2) pre-programmed;
Lumen (approximately 72 minutes) and
Non-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 Challenge
Device /
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 with
polypropylene sterilization wrap, rigid containers |
5
6
STERLINK™ FPS-15s Plus Sterilizer with STERLOAD™ Cassette 510(k) Summary – K212200
7
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 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 | |
| Shelf-life test | ||
| (Sterilant Preservation Test) | Manufacturer's internal standard | 1 year |
| Biocompatibility | ISO 10993-5:2009 | 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 | |
| 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 | |
| RF disturbance | EN 55011:2009/A1:2010 | Pass |
| Electromagnetic compatibility | ||
| (EMC) | EN 61326-1:2013 | |
| EN 61000-3-2:2014 | ||
| EN 61000-3-3:2013 | ||
| EN 60601-1-2:2015 | Pass | |
| Resistance validation for biological | ||
| indicator test | ISO 11138-1:2017 | Pass |
8
| 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 14937:2009 | |
| ISO 11737-1:2018 | ||
| ISO 11737-2:2009 | Pass | |
| Mated surface sterilization | ISO 14937:2009 | |
| ISO 11737-1:2018 | ||
| ISO 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 D638 | |
| ASTM E8/E8M-16ae1 | ||
| ASTM D790 | ||
| ASTM E290-14 | ||
| ASTM D256 | ||
| ASTM E23-18 | ||
| ASTM E1164 | ||
| ASTM E313 | ||
| ASTM D3985 | ||
| ASTM F1249 | Pass | |
| Delivery validation | ASTM D4169-14 | Pass |
| Hydrogen peroxide gas detection | ||
| test | 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.