Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical sterilization device and its process, with no mention of AI or ML capabilities in its operation or analysis.

Therapeutic

No
This device is a sterilizer for medical instruments, not a device used to treat or diagnose patients.

Diagnostic

No

This device is a sterilizer. Its purpose is to sterilize medical devices, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "low temperature sterilizer" consisting of a "main device and cassettes" containing hydrogen peroxide, indicating it is a physical hardware device with chemical components, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the terminal sterilization of reusable metal medical devices used in healthcare facilities. This is a process applied to medical devices themselves, not a test performed on biological samples to diagnose a condition.
Device Description: The device is a sterilizer that uses vaporized hydrogen peroxide to inactivate microorganisms on medical devices. This is a sterilization process, not a diagnostic test.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition

The device is clearly intended for the reprocessing of medical instruments to make them safe for reuse, which falls under the category of medical device sterilization, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 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,

Product codes

MLR

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.

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 using the following standards and/or guidance documents:

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) - Result: Pass
Shelf-life test (Sterilant Preservation Test) (Manufacturer's internal standard) - Result: 1 year
Biocompatibility (ISO 10993-5:2009) - Result: 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) - Result: 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) - Result: Pass
RF disturbance (EN 55011:2009/A1:2010) - Result: Pass
Electromagnetic compatibility (EMC) (EN 61326-1:2013 EN 61000-3-2:2014 EN 61000-3-3:2013 EN 60601-1-2:2015) - Result: Pass
Resistance validation for biological indicator test (ISO 11138-1:2017) - Result: Pass
Lumen sterilization (ISO 14937:2009) - Result: Pass
Surface sterilization (ISO 14937:2009 ISO 11737-1:2018 ISO 11737-2:2009) - Result: Pass
Mated surface sterilization (ISO 14937:2009 ISO 11737-1:2018 ISO 11737-2:2009) - Result: Pass
Simulated use test (ASTM E1837-96:2014 ISO 11737-1:2018) - Result: Pass
In-use test (ASTM E1837-96:2014) - Result: Pass
Sporicidal activity test (AOAC 966.04 (AOAC 6.3.05:2013)) - Result: Pass
Bacteriostasis test (ISO 11737-1:2018) - Result: 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) - Result: Pass
Delivery validation (Sterilizer) (ASTM D4169-14) - Result: Pass
Delivery validation (Sterilant) (Manufacturer's internal standard) - Result: Pass
Hydrogen peroxide gas detection test (OSHA analytical method 1019) - Result: Pass

Key Results: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K212200

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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

1

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 LLC
1783 Forest Drive
Suite 254
Annapolis, MD 21401
Tel: +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 Classification
Name	Ethylene oxide gas sterilizer	Same
Classification Product
Code	MLR	Same
Regulation Number	21 CFR 880.6860	Same
	Subject Device	Predicate Device
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
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 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

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510(k) Summary – K223015

6

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
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 (AOAC 6.3.05:2013)	Pass
Bacteriostasis test	ISO 11737-1:2018	Pass
Test	Standard/Guidance Document	Result
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 (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.