(399 days)
No
The device description relies on a mechanical principle (spring-loaded piston reacting to pressure) to provide a visual cue, not on AI/ML algorithms. There are no mentions of AI, ML, or related concepts in the provided text.
No.
The device facilitates guidewire-assisted catheter placement by providing visual cues for blood vessel entry; it does not treat or cure a disease or condition.
No
The device is intended to facilitate guidewire-assisted catheter placement and provides a visual cue when it hits a vessel with >50mmHg of pressure, indicating placement, not diagnosing a condition.
No
The device description clearly describes a physical syringe with a spring-loaded piston, indicating it is a hardware device, not software-only.
Based on the provided information, the EpiFaith CV is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- EpiFaith CV Function: The EpiFaith CV is a mechanical device used during a medical procedure (central venous catheter placement). Its function is to provide a visual cue based on pressure differences within a blood vessel, helping the user confirm the needle tip placement. It does not analyze a specimen taken from the body.
- Intended Use: The intended use clearly states it's for use in the central venous catheter placement procedure to facilitate guidewire-assisted placement.
- Device Description: The description focuses on the mechanical action of the piston in response to pressure, not on analyzing a biological sample.
Therefore, the EpiFaith CV is a medical device used in a procedural context, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DQX
Device Description
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.
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
Neonates and infants shall be excluded from the intended population.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 including Biocompatibility tests (Cytotoxicity, Sensitization, Irritation or intracutaneous reactivity, Acute systemic toxicity, Material-medicated pyrogenicity, Hemocompatibility, Endotoxin), Sterilization tests (Sterilization validation, Sterility test, Bioburden & Recovery test, EO residue), and Shelf life and performance bench tests (Seal strength test, Bubble leak test, Sterility test, Negative pressure leakage, Positive pressure leakage, Auto-aspirating mechanism, Positive pressure indication, Resistance of passing guidewire, Fatigue tests of latches, Fluid leakage - Positive pressure liquid leakage, Sub-atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load). All tests passed.
No clinical or animal testing data was included in the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
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.
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
2
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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3
510(k) Summary
1. Submitter
| Name | Flat Medical Co., Ltd. | |
|---|---|---|
| Address | 9F.-1, No. 27, Sec. 1, Chang'an E. Rd., Zhongshan | |
| Dist., 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 |
4
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.
5
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.
6
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 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 Arrow Raulerson | ||
| Syringe is indicated for use | |||
| with spring-wire guides | |||
| ranging from .025" (.64 mm) | |||
| to .038" (.96 mm) and | |||
| spring-wire guide | |||
| introduction needles sized | |||
| to place these wires. The | |||
| syringe allows for vessel | |||
| location and passage of the | |||
| guidewire through the | |||
| syringe obviating the need | |||
| for separating the introducer | |||
| needle from the syringe. | 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. | |||
| Applicable | |||
| Guidewire | |||
| range | 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 materials | ||
| Stainless steel | |||
| Elastomer | Plastic materials | ||
| Stainless steel | |||
| Elastomer | Polypropylene | ||
| Synthetic & silicone rubber | |||
| Stainless steel. | |||
| Lubricant | Silicone oil | - | Silicone oil |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 |
| Sterilization | |||
| method | E.O gas sterilization | ||
| Sterile assurance level: 10-6 | E.O gas sterilization | E.O gas sterilization | |
| Sterile assurance level: 10-6 | |||
| Packaging | Individually packaged or as | ||
| part of a kit. | Individually packaged or as | ||
| part of a kit. | Individually packaged in a | ||
| Tyvek pouch |
7
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 intracutaneous | ||
| reactivity | ISO 10993-10:2010 | Pass |
| Acute systemic toxicity | ISO 10993-11:2017 | Pass |
| Material-medicated pyrogenicity | USP | Pass |
| Hemocompatibility | ISO 10993-4:2017 & ASTM F756 | Pass |
| Endotoxin | USP & USP | 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 pressure | ||
| liquid leakage | ISO 80369-7:2016 & ISO 80369- | |
| 20:2015 | Pass | |
| Sub- atmospheric pressure air | ||
| leakage | ISO 80369-7:2016 & ISO 80369- | |
| 20:2015 | Pass | |
| Stress cracking | ISO 80369-7:2016 & ISO 80369- | |
| 20:2015 | Pass | |
| Resistance to separation from | ||
| axial 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.
8
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.