EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space.

Device Description

The EpiFaith is a loss of resistance syringe with spring loaded piston, which can provide a means for detecting entry into the epidural space. Based on the principle of LOR technique, the piston will simultaneously move forward when the pressure drop occurs due to the spring force. The moving of the piston can provide a visual signal to indicate the LOR as well as verify the needle tip placement in the epidural space. The EpiFaith syringe is compatible to a 16-18 gauge epidural needle with Luer or NRFit connector. The user can push the plunger to increase the pressure after the syringe is connected to an inserted needle. Then, the user can advance the needle until the visual signal occurring. Because the piston is spring loaded, the automatic ejection of the syringe will happen when the LOR occurring, resulting in the movement of the piston. There are two different models of EpiFaith Syringe. The proposed models are listed below. The only difference between two models is the type of the connector.

AI/ML Overview

This document, K192421, is a 510(k) summary for the EpiFaith Syringe. It describes the device, its intended use, and a comparison to a predicate device (K182268) to demonstrate substantial equivalence.

It's important to note that this 510(k) submission is for a medical device (a syringe), not an AI/ML-enabled medical device. Therefore, the questions related to AI/ML performance, ground truth, human readers, and training/test sets are not directly applicable to this document. The "Performance Data" section discusses traditional non-clinical tests for a medical syringe.

However, I will extract the available information as best as possible, interpreting "acceptance criteria" and "device performance" in the context of a non-AI/ML medical device.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, acceptance criteria relate to its physical properties and functional performance as a syringe, not diagnostic or predictive accuracy. The performance data is based on non-clinical tests.

Acceptance Criterion (Type of Test)	Reported Device Performance (Summary from document)
Risk assessment (ISO 14971: 2007)	Conducted, suggesting risks are assessed and managed.
Friction forces test (ISO 7886-1: 2017)	Conducted, implying the device meets the standard for plunger movement.
Liquid leakage test (ISO 7886-1: 2017)	Conducted, implying the device meets the standard for fluid containment.
Biocompatibility Assessment (ISO 10993: In vitro cytotoxicity, Skin sensitization, Intracutaneous irritation, Acute systemic toxicity, Pyrogen test, Limulus amebocyte lysate endotoxin)	Meets guidelines, indicating the materials are safe for biological contact.
Sterility (Sterile assurance level)	10^-6 (E.O gas sterilization), indicating a very low probability of non-sterile product.
Packaging Integrity	"Tyvek and PET", implying standard medical packaging.
Compliance with ISO 80369-6 (NRFit)	Yes (for NRFit model) - indicates connector compatibility.
Compliance with ISO 80369-7 (Luer slip)	Yes (for Luer slip model) - indicates connector compatibility.

The document states: "Design Verification activities were performed on subject device and all necessary tests were verified to meet the required acceptance criteria." and "the material change of syringe piston meets the requirements that are considered essential for its intended use".

2. Sample size used for the test set and the data provenance

This document does not specify exact sample sizes for the non-clinical tests (e.g., how many syringes were tested for friction or leakage). The tests are typically performed on a statistically relevant sample size according to the respective ISO standards. The data provenance is from Flat Medical Co., Ltd., Taipei City, Taiwan, the device manufacturer. The tests are non-clinical (bench testing), not retrospective or prospective human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the validation is for a physical medical device (syringe) performing mechanical and biocompatibility functions, not an AI/ML model requiring expert review for diagnostic ground truth. The "ground truth" for these tests are objective measurements (e.g., force, leakage presence/absence, biochemical reactions).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication typically refers to expert consensus in diagnostic studies, which is not relevant here. The tests are based on objective, measurable criteria defined by international standards.

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 not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on objective measurements and adherence to established international standards (e.g., ISO 7886-1 for syringes, ISO 10993 for biocompatibility). For example, a "friction force" reading compared against a defined maximum in the standard, or absence of leakage as per the standard.

8. The sample size for the training set

Not applicable. This is a manufactured physical device, not an AI/ML model that undergoes a "training" phase.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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September 27, 2019

Flat Medical Co., Ltd Shao Wei Tseng Cheif of Regulatory Officer 9F-1., No27, Sec.1, Chang' An E. Rd., Zhongshan Dist., Taipei City 10441, Taiwan

Re: K192421

Trade/Device Name: EpiFaith Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: August 28, 2019 Received: September 4, 2019

Dear Shao Wei Tseng:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K192421

Device Name EpiFaith Syringe (Luer Slip) EpiFaith Syringe (NRFit)

Indications for Use (Describe)

EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space.

Type of Use (Select one or both, as applicable)
	Residential
	Commercial

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K192421

1. Submitter

Title: Chief of Regulatory Officer Email: shaowei@flatmedical.com Telephone number: +886-2-25672959 #13 Flat Medical Co., Ltd. Address: 9F.-1, No. 27, Sec. 1, Chang'an E. Rd., Zhongshan Dist., Taipei City 10441, Taiwan

Date of Preparation August 28, 2019

Subject Device 2.

Name of Device:	EpiFaith Syringe (Luer Slip), EpiFaith Syringe (NRFit)
Common/Usual Name:	Syringe, Piston
Device Classification:	Class II
Classification Name:	Piston Syringe
Regulation Number	21 CFR 880.5860
Product Code:	FMF

Image /page/3/Picture/9 description: The image contains the logo for Flat Medical. The logo consists of a blue and gray icon to the left of the text "Flat Medical". Below the text is the phrase "Safe care for All" in a smaller font.

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Predicate Devices 3.

Name of Device:	EpiFaith Syringe (Luer Slip), EpiFaith Syringe (NRFit)
Common/Usual Name:	Syringe, Piston
Device Classification:	Class II
Classification Name:	Piston Syringe
Regulation Number	21 CFR 880.5860
Product Code:	FMF
Premarket Notification	K182268

Device Description and technology Characteristics 4.

Flat Medical EpiFaith Syringe
Model #	Connector type
FM-01SLR	Luer slip
FM-02SNR	NRFit

5. Intended Use

EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space.

Image /page/4/Picture/8 description: The image shows the logo for Flat Medical. The logo consists of a gray and blue symbol on the left, followed by the words "Flat Medical" in blue and gray. Below the word "Medical" is the phrase "Safe care for All" in a smaller font.

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ELEMENT OFCOMPARISON	SUBJECT DEVICE	CLAIM SUBSTANTIALLY EQUIVALENTDEVICE
Trade name	EpiFaith Syringe	EpiFaith Syringe
510(k) number	To be determined	K182268
Regulation Number	21 CFR 880.5860
Regulation Name	Piston Syringe
Regulatory Class	II
Product Code	FMF
Syringe type	Piston Syringe
Intended use	EpiFaith Syringe is intended for use with an epidural needle for detecting a loss ofresistance, which aids a clinician in verifying needle tip placement in the epidural space.
Principle of operation	EpiFaith Syringe is based on the principle of LOR, loss of resistance
Nozzle type	There are two models.Luer slip (follow ISO 80369-7)NRFit (follow ISO 80369-6)
Lubricant	Silicone oil
Reuse durability	Single use only
Material	polypropylenesynthetic & silicone rubberstainless steel.	polypropylenesynthetic & natural rubberstainless steel.
Biocompatibility	Meets guidelines presented in Use of International Standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1: Evaluation and testing within a risk managementprocess.
Sterilization method	E.O gas sterilizationSterile assurance level : 10-6
Applicable standard	ISO 7886-1ISO 80369-6ISO 80369-7
Packaging	Tyvek and PET

Comparison of Technological Characteristics with the Predicate Device 6.

This submission addressed a material change to the syringe piston. The indication for use, the principle of operation, and technological characteristics of the subject device are identical to the predicate device. The subject device is substantially equivalent to the predicate device.

Image /page/5/Picture/4 description: The image contains the logo for Flat Medical. The logo consists of a blue and gray icon to the left of the company name. The icon is made up of four curved shapes, two blue and two gray, arranged in a square. The text "Flat Medical" is written in blue, with the word "Flat" being larger than the word "Medical". Below the company name, in smaller gray text, is the phrase "Safe care for All".

Confidential

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Performance Data: 7.

Non-Clinical Tests

We have conducted non-clinical testing based on its risk assessment utilizing Failure Mode Effect Analysis (FMEA). The following evaluations were conducted to validate the modifications made to the subject device:

Risk assessment (ISO 14971: 2007)
-Friction forces test and liquid leakage test (ISO 7886-1: 2017)
-Biocompatibility Assessment per ISO 10993: In vitro cytotoxicity, Skin sensitization, Intracutaneous irritation, Acute systemic toxicity, Pyrogen test, Limulus amebocyte lysate endotoxin.

8. Conclusion

Based on the intended use, materials, design, biocompatibility testing and performance testing, the material change of syringe piston meets the requirements that are considered essential for its intended use and the subject device is considered substantially equivalent to the predicate device, the EpiFaith Syringe, cleared under K182268.

Substantial Equivalence

The subject device has the same intended use, technology, operation principle and the technical characteristics with the predicate device. Design Verification activities were performed on subject device and all necessary tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the material of syringe piston do not change the intended use of the device or raise different questions of safety and effectiveness. There are no significant differences between subject device and the predicate device(s) that would adversely affect the use of the product. We conclude that subject device is substantially equivalent to predicate devices.

Image /page/6/Picture/11 description: The image shows the logo for Flat Medical. The logo consists of a blue and gray symbol on the left, followed by the words "Flat Medical" in blue and gray. Below the word "Medical" is the phrase "Safe care for All" in a smaller font.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).