(399 days)
The EpiFaith CV is intended for use in central venous catheter placement procedure, which is designed to facilitate guidewire-assisted catheter placement and is compatible with guidewires ranging from 0.025"(0.64mm) to 0.038"(0.96mm) along with their appropriate introducer needles. The device provides a visual cue when it hits a vessel with >50mmHg of pressure. The EpiFaith CV will be sold sterile individually packaged, and as part of a sterile kit. Neonates and infants shall be excluded from the intended population.
The EpiFaith CV is a syringe with spring loaded piston, which can provide a high/low blood pressure signal when introducer needle tip entry to the blood vessel. Based on the principle of blood pressure differences in different blood vessel, the piston will simultaneously move backward when the pressure increase occurs due to the high blood pressure in the syringe barrel. The moving of the piston can provide a visual signal to indicate the high/low blood pressure as well as verify the introducer needle tip placement in the blood vessel.
The provided text describes the 510(k) submission for the EpiFaith CV device, which is a medical device intended for use in central venous catheter placement procedures. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving an AI algorithm, human readers, or image analysis. Instead, it details bench testing for physical and material properties of a medical device.
Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes for a test set, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as the document does not contain this type of information.
The document discusses "acceptance criteria" in the context of the non-clinical bench tests performed on the EpiFaith CV device to ensure its physical and material properties meet predetermined standards. These are not acceptance criteria for an AI system's performance metrics like sensitivity, specificity, or AUC.
Here's a breakdown of what the document does provide, in a format that relates to your request, but acknowledging the difference in context:
1. A table of acceptance criteria and the reported device performance:
The document lists various non-clinical tests performed on the EpiFaith CV device. The "acceptance criteria" are implied by the "Pass" results for each test. The reported "device performance" is simply that the device passed these tests, indicating it met the implicit criteria for acceptable functioning and safety.
| Test | Acceptance Criteria (Implied by "Pass" result) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | Meets ISO 10993-5:2009 standards | Pass |
| Sensitization | Meets ISO 10993-10:2010 standards | Pass |
| Irritation or intracutaneous reactivity | Meets ISO 10993-10:2010 standards | Pass |
| Acute systemic toxicity | Meets ISO 10993-11:2017 standards | Pass |
| Material-medicated pyrogenicity | Meets USP <151> standards | Pass |
| Hemocompatibility | Meets ISO 10993-4:2017 & ASTM F756 standards | Pass |
| Endotoxin | Meets USP <85> & USP <43> standards | Pass |
| Sterility test | Meets ISO 11737-2:2019 standards | Pass |
| Seal strength test | Meets ASTM F88 standards | Pass |
| Bubble leak test | Meets ASTM F2096 standards | Pass |
| Negative pressure leakage | Meets Flat Medical internal protocol | Pass |
| Positive pressure leakage | Meets Flat Medical internal protocol | Pass |
| Auto-aspirating mechanism | Meets Flat Medical internal protocol | Pass |
| Positive pressure indication | Meets Flat Medical internal protocol | Pass |
| Resistance of passing guidewire | Meets Flat Medical internal protocol | Pass |
| Fatigue tests of latches | Meets Flat Medical internal protocol | Pass |
| Fluid leakage - Positive pressure liquid leakage | Meets ISO 80369-7:2016 & ISO 80369-20:2015 | Pass |
| Sub-atmospheric pressure air leakage | Meets ISO 80369-7:2016 & ISO 80369-20:2015 | Pass |
| Stress cracking | Meets ISO 80369-7:2016 & ISO 80369-20:2015 | Pass |
| Resistance to separation from axial load | Meets ISO 80369-7:2016 & ISO 80369-20:2015 | Pass |
2. Sample sized used for the test set and the data provenance:
The document describes non-clinical bench testing. It does not specify "sample sizes" in the context of patient data or test sets for an AI algorithm. The tests were performed on physical units of the EpiFaith CV device. The data provenance is internal to Flat Medical Co., Ltd. through their internal protocols and compliance with various ISO and ASTM standards. The study is a non-clinical bench study, not a retrospective or prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the provided document. Ground truth as typically defined for AI models (e.g., expert annotations on medical images) is not relevant here. The "ground truth" equivalent for this device is whether it physically functions as designed and meets specified safety and performance standards, as evaluated by engineers and technicians during bench testing according to established protocols and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for expert review of data, not for bench testing of a physical device.
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 document is about a physical medical device (catheter guide wire accessory), not an AI system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" in this context is established engineering and safety standards (e.g., ISO, ASTM, USP) and the manufacturer's internal protocols. The device either passes or fails these pre-defined physical and material performance criteria.
8. The sample size for the training set:
Not applicable. There is no AI training set mentioned.
9. How the ground truth for the training set was established:
Not applicable. There is no AI training set.
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Image /page/0/Picture/0 description: The image contains 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.
September 21, 2022
Flat Medical Co., Ltd. Tseng Shao Wei Chief of Regulatory Officer 9F .- 1 No. 27, Sec. 1, Chang'an E. Rd. Zhongshan Dist. Taipei City, 10441 Taiwan
Re: K212615
Trade/Device Name: EpiFaith CV Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 16, 2022 Received: September 19, 2022
Dear Tseng Shao Wei:
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.
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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.
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular 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) K212615
Device Name EpiFaith CV
Indications for Use (Describe)
The EpiFaith CV is intended for use in central venous catheter placement procedure, which is designed to facilitate guidewire-assisted catheter placement and is compatible with guidewires ranging from 0.025"(0.64mm) to 0.038"(0.96mm) along with their appropriate introducer needles. The device provides a visual cue when it hits a vessel with >50mmHg of pressure. The EpiFaith CV will be sold sterile individually packaged, and as part of a sterile kit. Neonates and infants shall be excluded from the intended population.
| 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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510(k) Summary
1. Submitter
| Name | Flat Medical Co., Ltd. | |
|---|---|---|
| Address | 9F.-1, No. 27, Sec. 1, Chang'an E. Rd., ZhongshanDist., Taipei City 10441, Taiwan | |
| Contact Person | Shao Wei, Tseng | |
| Title | Chief of Regulatory Officer | |
| shaowei@flatmedical.com | ||
| Telephone number | +886-2-25672959#13 | |
| Date of Preparation | March 25, 2022 |
2. Subject Device
| Name of Device | EpiFaith CV | |
|---|---|---|
| Device Classification | Class II | |
| Classification Name | Catheter guide wire | |
| Regulation Medical | Cardiovascular | |
| Specialty | ||
| Regulation Number | 21 CFR 870.1330 | |
| Product Code: | DQX |
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3. Predicate Devices and reference device
Predicate device
| Name of Device | Introducer Safety Syringe |
|---|---|
| Common/Usual Name | Wire, Guide, Catheter |
| Device Classification | Class II |
| Classification Name | Catheter guide wire |
| Regulation Number | 21 CFR 870.1330 |
| Product Code | DQX |
| Premarket Notification | K884490 |
Reference device
| Name of Device | EpiFaith Syringe (Luer), 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 | K192421 |
Device Description and technology Characteristics 4.
The EpiFaith CV is a syringe with spring loaded piston, which can provide a high/low blood pressure signal when introducer needle tip entry to the blood vessel. Based on the principle of blood pressure differences in different blood vessel, the piston will simultaneously move backward when the pressure increase occurs due to the high blood pressure in the syringe barrel. The moving of the piston can provide a visual signal to indicate the high/low blood pressure as well as verify the introducer needle tip placement in the blood vessel.
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5. Intended Use
The EpiFaith CV is intended for use in central venous catheter placement procedure, which is designed to facilitate guidewire-assisted catheter placement and is compatible with guidewires ranging from 0.025" (0.64mm) to 0.038" (0.96mm) along with their appropriate introducer needles. The device provides a visual cue when it hits a vessel with>50mmHg of pressure. The EpiFaith CV will be sold sterile individually packaged, and as part of a sterile kit. Neonates and infants shall be excluded from the intended population.
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6. Comparison of Technological Characteristics with the Predicate Device and Reference Device
| Subject device | Predicate Device | Reference device | |
|---|---|---|---|
| EpiFaith CV | Introducer Safety Syringe(K884490) | EpiFaith Syringe(K192421) | |
| Intended Use | The EpiFaith CV is intendedfor use in central venouscatheter placementprocedure, which isdesigned to facilitateguidewire-assisted catheterplacement and is compatiblewith guidewires rangingfrom 0.025"(0.64mm) to 0.038"(0.96mm) along with theirappropriate introducerneedles. The deviceprovides a visual cue whenit hits a vesselwith>50mmHg of pressure.The EpiFaith CV will be soldsterile individually packaged,and as part of a sterile kit.Neonates and infants shallbe excluded from theintended population. | The Arrow RaulersonSyringe is indicated for usewith spring-wire guidesranging from .025" (.64 mm)to .038" (.96 mm) andspring-wire guideintroduction needles sizedto place these wires. Thesyringe allows for vessellocation and passage of theguidewire through thesyringe obviating the needfor separating the introducerneedle from the syringe. | EpiFaith Syringe is intendedfor use with an epiduralneedle for detecting a lossof resistance, which aids aclinician in verifying needletip placement in the epiduralspace. |
| ApplicableGuidewirerange | 0.025" (0.64mm) to 0.038"(0.96mm) | 0.025" (0.64mm) to 0.038"(0.96mm) | N/A |
| Connectivity | Luer (ISO 80369-7) | Luer | Luer (ISO 80369-7)NRFit (ISO 80369-6) |
| Nozzle type | Single Use | Single Use | Single Use |
| Material | Plastic materialsStainless steelElastomer | Plastic materialsStainless steelElastomer | PolypropyleneSynthetic & silicone rubberStainless steel. |
| Lubricant | Silicone oil | - | Silicone oil |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 |
| Sterilizationmethod | E.O gas sterilizationSterile assurance level: 10-6 | E.O gas sterilization | E.O gas sterilizationSterile assurance level: 10-6 |
| Packaging | Individually packaged or aspart of a kit. | Individually packaged or aspart of a kit. | Individually packaged in aTyvek pouch |
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7. Performance Data:
Non- Clinical Tests
| Biocompatibility test | ||
|---|---|---|
| Test | Standard | Results |
| Cytotoxicity | ISO 10993-5:2009 | Pass |
| Sensitization | ISO 10993-10:2010 | Pass |
| Irritation or intracutaneousreactivity | ISO 10993-10:2010 | Pass |
| Acute systemic toxicity | ISO 10993-11:2017 | Pass |
| Material-medicated pyrogenicity | USP <151> | Pass |
| Hemocompatibility | ISO 10993-4:2017 & ASTM F756 | Pass |
| Endotoxin | USP <85> & USP <43> | Pass |
| Sterilization | ||
| Test | Standard | Results |
| Sterilization validation | ISO 11135:2014 | |
| Sterility test | ISO 11737-2:2019 | Pass |
| Bioburden & Recovery test | ISO 11737-1:2018 | |
| EO residue | ISO 10993-7:2008 | |
| Shelf life and performance bench test | ||
| Test | Standard | Results |
| Seal strength test | ASTM F88 | Pass |
| Bubble leak test | ASTM F2096 | Pass |
| Sterility test | ISO 11737-2:2019 | Pass |
| Negative pressure leakage | Flat Medical internal protocol | Pass |
| Positive pressure leakage | Flat Medical internal protocol | Pass |
| Auto-aspirating mechanism | Flat Medical internal protocol | Pass |
| Positive pressure indication | Flat Medical internal protocol | Pass |
| Resistance of passing guidewire | Flat Medical internal protocol | Pass |
| Fatigue tests of latches | Flat Medical internal protocol | Pass |
| Fluid leakage - Positive pressureliquid leakage | ISO 80369-7:2016 & ISO 80369-20:2015 | Pass |
| Sub- atmospheric pressure airleakage | ISO 80369-7:2016 & ISO 80369-20:2015 | Pass |
| Stress cracking | ISO 80369-7:2016 & ISO 80369-20:2015 | Pass |
| Resistance to separation fromaxial load | ISO 80369-7:2016 & ISO 80369-20:2015 | Pass |
Clinical Tests
The submission does not contain clinical data. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests
The submission does not contain animal testing data.
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8. Conclusion
Based on the intended use, materials, design, and performance testing, the EpiFaith CV meets the requirements that are considered essential for its intended use and is considered substantially equivalent to the predicate device, the Introducer Safety Syringe, K884490.
Substantial Equivalence
The subject device has same intended use, technology, operation principle and 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 or raise any unsolved issues. There is no significant difference between subject device and the predicate device that would adversely affect the use of the product. We conclude that subject device is substantially equivalent to predicate devices.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.