(227 days)
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.
The EpiFaith is a loss of resistance syringe with a spring-loaded piston, which can provide a means for detecting entry into the epidural space. Based on the principle of the 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 assist in verifying 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 occurs. Because the piston is spring loaded, the automatic ejection of the content of the syringe will happen when the LOR occurs, resulting in the movement of the piston. There are two different models of EpiFaith Syringe. The proposed models are listed in Table 4.1. The only differences between two models are the type of the connector and color.
The provided text describes a 510(k) submission for the EpiFaith Syringe, a loss-of-resistance syringe used for detecting entry into the epidural space. This document is a summary and primarily focuses on demonstrating substantial equivalence to a predicate device (AutoDetect Syringe K041590) through characterization and non-clinical performance testing.
The document does not include information on a clinical study (MRMC, standalone, or otherwise) involving human readers or expert consensus for establishing ground truth from clinical images. The performance data described are exclusively non-clinical bench tests and compliance with recognized standards.
Therefore, many of the requested items related to clinical study design, sample sizes for test/training sets, expert consensus, and human reader performance are not applicable or not present in this 510(k) summary.
Here's a breakdown of the information that is available based on the provided text:
Acceptance Criteria and Device Performance (Non-Clinical)
The performance data for the EpiFaith Syringe are entirely based on non-clinical bench testing and adherence to recognized standards. The acceptance criteria are implicitly defined by compliance with these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by adherence to standards) | Reported Device Performance |
|---|---|
| ISO 7886-1:2017 (Sterile hypodermic syringes for single use – Part 1: Syringes for manual use) | "The EpiFaith Syringe complies with the FDA recognized consensus standards: ISO 7886-1:2017... Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." (Implies successful performance across all relevant parameters of the standard, e.g., dimensions, capacity, sterility, luer connection, plunger operation). |
| ISO 80369-6:2016 (Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications) | "The EpiFaith Syringe complies with the FDA recognized consensus standards: ... ISO 80369-6:2016... Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." (Implies successful performance related to the NRFit connector specifications). |
| ISO 80369-7:2016 (Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications) | "The EpiFaith Syringe complies with the FDA recognized consensus standards: ... ISO 80369-7:2016, as outlined within this submission. Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." (Implies successful performance related to the Luer slip connector specifications). |
| ISO 80369-20:2015 (Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods) | "Conformity to these standards demonstrates that the proposed EpiFaith Syringe met the standards' established acceptance criteria for the device." (Indicates application of common test methods and successful results.) |
| ISO 10993-1, -4, -5, -7, -10, -11 (Biological Evaluation of Medical Devices – various parts) | "The biocompatibility evaluation for the EpiFaith Syringe was conducted in accordance with the FDA Guidance Document... and International Standard ISO 10993-1... Testing included the following: Hemolysis, In vitro cytotoxicity, Skin sensitization, Intracutaneous irritation, Acute systemic toxicity, Material-Mediated Pyrogens, Limulus amoebocyte lysate endotoxin." (Implies all these tests passed per the ISO 10993 standards). |
| ASTM F1980-16, ISO 11135, ASTM F1140, ASTM F1608-00, ISO 15223-1, ASTM F756-17, USP <85>, USP <151>, USP <161>, ISO 28590, ASTM F88, ASTM F1886, ASTM F1929, ISO 11737-2, ISO 14971, USP <788> (Sterilization, Packaging, Labeling, Pyrogenicity, Quality Mgmt, Particulate Matter, etc.) | "A battery of tests was performed based on the requirements of the below recognized consensus standards and guidance, as well as biocompatibility, sterilization, and packaging standards and guidance. Conformity to these standards demonstrates that the proposed EpiFaith Syringe met the standards' established acceptance criteria for the device." (Implies successful performance across all listed standards). |
| Performance Bench Testing: Visual indicator response time, Needle protruding length and visual indicator activation on an epidural simulator, Resistance of the O-ring, Human Factors and Usability Testing on an epidural simulator | "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." (Implies these specific bench tests were successfully completed and met internal acceptance criteria to support intended use). |
Information Not Present in the Provided Document:
The following requested items are typically associated with clinical studies, especially those involving AI/imaging devices, and are not found in this 510(k) summary as it pertains to a mechanical medical device (syringe):
- Sample sizes used for the test set and the data provenance: Not applicable; no clinical test set data presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical ground truth established from expert readings.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no clinical test set.
- 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: No MRMC study was done, as this is a mechanical syringe, not an AI/imaging device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone algorithm performance provided, as this is a mechanical syringe.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. The "ground truth" for this device would be defined by the physical and material properties meeting the specifications of the listed international standards.
- The sample size for the training set: Not applicable; no training set data relevant to AI/machine learning.
- How the ground truth for the training set was established: Not applicable; no training set ground truth relevant to AI/machine learning.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study proving the EpiFaith Syringe meets its acceptance criteria is a series of non-clinical bench tests and evaluations demonstrating compliance with a comprehensive list of international and consensus standards for piston syringes, biocompatibility, sterilization, packaging, and specific functional performance metrics (e.g., visual indicator response, O-ring resistance, human factors on a simulator). The document states that "Conformity to these standards demonstrates that the proposed EpiFaith Syringe met the standards' established acceptance criteria for the device." The rationale for substantial equivalence relies on these non-clinical tests showing the device performs comparably to the predicate and meets its intended use. No clinical trials or studies involving human patients or complex data interpretation (like AI in imaging) were conducted or are required for this type of device and submission.
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K182268 510(k) Summary
- Submitter 1. Official Contact Name: Shao Wei, Tseng Title: Chief of Regulatory Officer Email: shaowei@flatmedical.com Telephone number: +886-2-25672959 #13 Flat Medical Co., Ltd. Address: Rm. 1, 9F., No. 27, Sec. 1, Chang'an E. Rd., Zhongshan Dist., Taipei City 10441, Taiwan April 4, 2019 Date of Preparation 2. Subject Device EpiFaith Syringe (Luer Slip), EpiFaith Syringe (NRFit) Name of Device: Syringe, Piston Common/Usual Name:
- Class II Device Classification: Piston Syringe Classification Name: 21 CFR 880.5860 Regulation Number Product Code: FMF
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3. Predicate Devices
| Name of Device: | AutoDetect Syringe |
|---|---|
| Common/Usual Name: | Syringe, Piston |
| Device Classification: | Class II |
| Classification Name: | Piston Syringe |
| Regulation Number | 21 CFR 880.5860 |
| Product Code: | FMF |
| Premarket Notification | K041590 |
4. Device Description and technology Characteristics
The EpiFaith is a loss of resistance syringe with a spring-loaded piston, which can provide a means for detecting entry into the epidural space. Based on the principle of the 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 assist in verifying 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 occurs. Because the piston is spring loaded, the automatic ejection of the content of the syringe will happen when the LOR occurs, resulting in the movement of the piston. There are two different models of EpiFaith Syringe. The proposed models are listed in Table 4.1. The only differences between two models are the type of the connector and color.
| Flat Medical EpiFaith Syringe | |
|---|---|
| Model # | Connector type |
| FM-01SLR | Luer slip |
| FM-02SNR | NRFit |
Table 4.1: Proposed models of Flat Medical EpiFaith Syringe
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5. Indications for 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.
| ELEMENT OFCOMPARISON | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| Trade name | EpiFaith Syringe | AutoDetect Syringe |
| 510(k) number | K182268 | K041590 |
| Regulation Number | 21 CFR 880.5860 | 21 CFR 880.5860 |
| Regulation Name | Piston Syringe | Piston Syringe |
| Regulatory Class | II | II |
| Product Code | FMF | FMF |
| Syringe type | Piston Syringe | Piston Syringe |
| Intended use | EpiFaith Syringe is intended for use with anepidural needle for detecting a loss ofresistance, which aids a clinician in verifyingneedle tip placement in the epidural space. | The AutoDetect Syringe is intended for usewith an epidural needle for the verificationof needle tip placement in the epiduralspace. |
| Principle of operation | EpiFaith Syringe is based on the principle ofLOR, loss of resistance | The AutoDetect Syringe is based on theprinciple of LOR, loss of resistance |
| Nozzle type | There are two models.Luer slip (follow ISO80369-7)NRFit (follow ISO80369-6) | - |
| Lubricant | Silicone oil | - |
| Reuse durability | Single use only | - |
| Material | Polypropylene | Polypropylene |
| natural & synthetic rubber | Silicone | |
| The spring is made of stainless steel. | Polycarbonate | |
| Biocompatibility | Meets guidelines presented in Use ofInternational Standard ISO 10993-1,"Biological evaluation of medical devices –Part 1: Evaluation and testing within a riskmanagement process. | Meets guidelines presented in ISO 10993-1:2009. |
| Sterilization method | E.O gas sterilizationSterile assurance level : 10-6 | - |
| Dimensions | Length:103.0mm to 134.0mm | - |
| Outer diameter of barrel:14.6mm | ||
| Weight: 7.0g | ||
| Maximum usable capacity:4ml | ||
| Applicable standard | ISO 7886-1ISO 80369-6ISO 80369-7 | ISO 7886-1 |
| Packaging | Single device is contained in an E.O. gaspermeable bag as the sterile barrier. Thebag is made by Tyvek and PET with200mm75mm of dimension. Fifty bags arecontained in a folding carton(205175*160mm). | - |
Comparison of Technological Characteristics with the Predicate Device 6.
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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 tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the device do not affect the intended use of the device. 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 the predicate device.
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7. Performance Data:
Non-Clinical Tests
| FDA guidance and recognized consensus standards have beenestablished for Piston Syringes under FDA Product Code FMFand 21 CFR 880.5860. A battery of tests was performed basedon the requirements of the below recognized consensusstandards and guidance, as well as biocompatibility,sterilization, and packaging standards and guidance.Conformity to these standards demonstrates that the proposedEpiFaith Syringe met the standards' established acceptancecriteria for the device. | ||
|---|---|---|
| PerformanceData | ISO 7886-1:2017, Sterile hypodermic syringes for singleuse – Part 1: Syringes for manual use ISO 80369-6:2016, Small-bore connectors for liquids andgases in healthcare applications – Part 6: Connectors forneuraxial applications ISO 80369-7: 2016, Small-bore connectors for liquids andgases in healthcare applications - Part 7: Connectors forintravascular or hypodermic applications | |
| ISO 80369-20: 2015, Small-bore connectors for liquids andgases in healthcare applications – Part 20: Common testmethods ISO 10993-1, Biological Evaluation Of Medical Devices -Part 1: Evaluation And Testing Within A Risk ManagementProcess ISO 10993-4, Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood ISO 10993-5, Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity | ||
| PerformanceData cont'd | • | ISO 10993-7, Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals |
| • | ISO 10993-10, Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization | |
| • | ISO 10993-11, Biological evaluation of medical devices—Part 11: Tests for systemic toxicity | |
| • | ASTM F1980-16, Standard Guide for Accelerated Aging ofSterile Barrier Systems for Medical Devices | |
| • | ISO 11135, Sterilization of health-care products – Ethyleneoxide - Requirements for the development, validation androutine control of a sterilization process for medical devices | |
| • | ASTM F1140, Standard Test Methods for InternalPressurization Failure Resistance of UnrestrainedPackages | |
| • | ASTM F1608-00, Standard Test Method for MicrobialRanking of Porous Packaging Materials (ExposureChamber Method) | |
| • | ISO 15223-1, Medical devices—Symbols to be used withmedical device labels, labelling and information to besupplied—Part 1: General requirements | |
| • | ASTM F756-17, Standard Practice for Assessment ofHemolytic Properties of Materials | |
| • | USP <85>, Bacterial Endotoxins Test | |
| • | USP <151>, Pyrogenicity Test | |
| Performance | • | USP <161>, Medical Devices-Bacterial Endotoxin andPyrogen Tests |
| Data cont'd | ISO 28590, Sampling procedure for inspection by attributes Introduction to the ISO2859 series of standards for sampling for inspection by attributes ASTM F88, Standard Test Method for Seal Strength of Flexible Barrier Materials ASTM F1886, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection ASTM F1929, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration ISO 11737-2, Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process ISO 14971, Medical devices. Application of risk management to medical devices USP <788>, Particulate Matter in Injections | |
| Performance Bench Testing Visual indicator response time Needle protruding length and visual indicator activation on an epidural simulator Resistance of the O-ring Human Factors and Usability Testing on an epidural simulator The EpiFaith Syringe complies with the FDA recognized consensus standards: ISO 7886-1:2017 |
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O ISO 80369-6:2016 O ISO 80369-7:2016, as outlined within this submission. Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use. Biocompatibility testing The biocompatibility evaluation for the EpiFaith Syringe was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process, June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Management Process," as recognized by FDA. Testing included the following: ● Hemolysis ● In vitro cytotoxicity ● Skin sensitization ● Intracutaneous irritation O Acute systemic toxicity ● Material-Mediated Pyrogens 0 Limulus amoebocyte lysate endotoxin The EpiFaith Syringe is considered tissue/bone/dentin contacting for a duration of less than 24 hours.
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8. Conclusion
Based on the intended use, materials, design, and performance testing, the EpiFaith Syringe meets the requirements that are considered essential for its intended use and is considered substantially equivalent to the predicate device, the AutoDetect Syringe, K041590.
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Flat Medical Co., Ltd. Shao-Wei Tseng Chief Regulatory Officer Rm. 1, 9F., No.27, Sec.1, Chang' an E. Rd., Zhongshan Dist. Tainei. 10441 Tw
Re: K182268
Trade/Device Name: EpiFaith Syringe (Luer Slip), EpiFaith Syringe (NRFt) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: February 27, 2019 Received: March 5, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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, fi 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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004 Indications For Use
1
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182268
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) | Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
|---|---|---|---|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||||
| Prescription Use (Part 21 CFR 801 Subpart D) | |||||||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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§ 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).