(127 days)
The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafety IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter are safety medical devices used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient. The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter are comprised of the following components: protective needle cover, color-coded catheter hub, radiopaque catheter tube, catheter holder, needle guide, medical grade stainless steel needle hub, porous plug and gauge chamber. The components combine for an ergonomic design that incorporate a safety feature that when the device is withdrawn, the needle is completely enclosed within the chamber protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded post-use. The retraction mechanism is activated by the push of a button.
This document describes the safety and performance testing for the MedSource TrueSafe Safety IV Catheter and MedSource TrueSafe Comfort Safety IV Catheter.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Criteria | Result |
|---|---|---|
| Needle Point | Free from foreign parts with no blunt needles or dents | Pass |
| Flow Rate Through Catheter | Flow rate should be 55ml/min | Pass |
| Corrosion Resistance Test | There shall be no sign of corrosion | Pass |
| Method for Determining Tensile Force at Break | Minimum force at break shall be $\geq 5N$ | Pass |
| Catheter Collapse Through Aspiration Test | There shall be no ingress of air bubbles into the syringe | Pass |
| Gauging Test | NO-GO side of the steel gauge should not be inside the luer. | Pass |
| Liquid Leakage From Conical Fitting Assembly Under Pressure | No liquid leakage should be there, when the assembly is subjected to withstand a pressure of 3.0 to 3.2 bar for 30sec. | Pass |
| Air Leakage from the Conical Fitting Assembly During Aspiration | There should be no air bubble formation from the assembly up to 15sec. | Pass |
| Separation Force of Conical Fitting Assembly | There should be no detachment while applying a force of 10 newtons away from the fixture. | Pass |
| Stress Cracking | There should not be any sign of cracking in the device luer fitting | Pass |
| Unscrewing Torque of Fitting Assembly | There shall be no separation when the fitting is tested | Pass |
| Ease of Assembly | Male reference fitting should insert without any jerk and fit together securely. | Pass |
| Resistance to Overriding | There shall not be any unusual damage on either of the female part or to the reference fitting. | Pass |
| Radiopacity of Catheter | Visually compare the images of the test specimen to the background on the film. | Pass |
| Catheter Elongation Testing | Measure the gauge length and tensile strength at break | Pass |
| Catheter Stiffness Testing | As per manufacturer data, Shore: D-60 ± 4 | Pass |
| Resistance to Disinfection | No visual damage shall be present. As per ISO 527, the catheter shall show no degradation in tensile properties. Catheter tube elongation should be greater than 100% (as in control i.e., non-exposed samples) | Pass |
| Needle Hub Detachment Force | 20N when testing needles of nominal O.D $\geq$ 0.6 mm | Pass |
| Needle Safety Mechanism Activation Test | Check whether the activation Lever activated smoothly without any jerk and check the complete length of the needle enclose to the safety chamber. | Pass |
| Venipuncture Process: Needle Stick (Max Penetration Load) | 14G: 2.70N; 16G: 2.50N; 17G: 2.40N; 18G: 1.90N; 20G: 1.60N; 22G: 1.50N; 24G: 1.35N; 26G: 1.30N | Pass |
| Venipuncture Process: Needle Stick (Max Friction) | 14G: 0.70N; 16G: 0.60N; 17G: 0.60N; 18G: 0.50N; 20G: 0.40N; 22G: 0.35N; 24G: 0.34N; 26G: 0.45N | Pass |
| Venipuncture Process: Tightness Between Catheter Tube and Cannula Activation Testing | The distance should not exceed maximum value of 1.0mm and should be greater than 0.1mm. 97.5% confidence that the failure rate would be no higher than 0.7% and 99.5% confident that the failure rate is not higher than 1.1%. | Pass |
| Biocompatibility (Sensitization Testing) | Standard ISO 10993 Part 10 | Pass |
| Biocompatibility (Intracutaneous Reactivity Test) | Standard 10993 Part 5 | Pass |
| Biocompatibility (In-Vitro Cytotoxicity) | Standard ISO 10003 Part 5 | Pass |
| Biocompatibility (Systemic Toxicity) | Standard ISO 10993 Part 11 | Pass |
| Biocompatibility (Hemocompatibility Test) | Standard ISO 10993-1 | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions several types of testing:
- Nonclinical Bench Performance testing: The specific sample sizes for each of the listed bench tests (e.g., flow rate, corrosion, tensile strength) are not explicitly provided in the summary. However, these are generally performed on a sufficient number of units to demonstrate compliance with the referenced ISO standards.
- Simulated Clinical Use Testing: This test used a sample size of 500 units.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a 510(k) submission and the tests are bench and simulated clinical use, they are inherently prospective in nature, performed specifically for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
For the nonclinical bench tests and simulated clinical use testing described, there is no mention of "experts" in the sense of medical professionals establishing a ground truth. These tests rely on predefined engineering and scientific criteria (e.g., ISO standards, physical measurements). The "ground truth" for these tests is the objective measurement against the specified criteria.
4. Adjudication Method for the Test Set:
Not applicable. The tests described are objective, quantitative measurements or visual assessments against predefined criteria from standards (e.g., ISO standards). There is no "adjudication" necessary between multiple observers or experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not conducted or reported in this document. This submission focuses on the substantial equivalence of the device through bench and simulated use testing, not on comparative effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device (an IV catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used:
The ground truth for the performance tests is based on:
- Established engineering and performance standards: Primarily ISO 10555-1 and ISO 10555-5 for mechanical and functional aspects, and ISO 10993 series for biocompatibility.
- Objective physical measurements: For parameters like flow rate, tensile force, needle stick force, distance measurements, etc.
- Visual inspection criteria: For aspects like needle point defects, corrosion, and resistance to disinfection.
- Pre-defined pass/fail criteria: For all tests, specific thresholds or observations determine a "Pass" or "Fail."
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product and not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this physical device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 3, 2016
MedSource International, LLC Ms. Laura Riggen Ouality & Regulatory Affairs Manager 401 Norex Drive Chaska, Minnesota 55318
Re: K161779
Trade/Device Name: MedSource TrueSafe Safety IV Catheter and MedSource TrueSafe Comfort Safety IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: October 4, 2016 Received: October 6, 2016
Dear Ms. Laura Riggen:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina Kiang -S
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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Indications for Use
510(k) Number (if known) K161779
Device Name
MedSource TrueSafe Safety IV Catheter and MedSource TrueSafe Comfort Safety IV Catheter
Indications for Use (Describe)
The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafety IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
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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FOR FDA USE ONLY
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510(K) Summary
Medsource International, LLC Submitter: 4201 Norex Drive Chaska, MN 55318
Contact Person: Laura Riggen, Quality and Regulatory Affairs Manager 4201 Norex Drive Chaska, MN 55318 Phone: 952-472-0131
Date Prepared: November 2, 2016
General Information:
Common Name: Catheter, intravascular, therapeutic, short-term Regulatory Reference: 21 CFR §880.5200 Regulation Name: Intravascular Catheter Product Code: FOZ Classification: Class II Panel: General Hospital Proprietary Name: MedSource TrueSafe Safety IV Catheter and MedSource TrueSafe Comfort Safety IV Catheter Predicate Device: MedSource IV Safety Catheter, K131555
Indications for Use:
The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
Description of the Device:
The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter are safety medical devices used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient.
The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter are comprised of the following components: protective needle cover, color-coded catheter hub, radiopaque catheter tube, catheter holder, needle guide, medical grade stainless steel needle hub, porous plug and gauge chamber. The components combine for an ergonomic design that incorporate a safety feature that when the device is withdrawn, the needle is completely enclosed within the chamber protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded post-use. The retraction mechanism is activated by the push of a button.
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| Part Number | Model Description | Color |
|---|---|---|
| MS-84414 | TrueSafe Safety IV Catheter 14 Gauge x 1.75" | Orange |
| MS-84416 | TrueSafe Safety IV Catheter 16 Gauge x 1.77" | Gray |
| MS-84418 | TrueSafe Safety IV Catheter 18 Gauge x 1.88" | Green |
| MS-844182 | TrueSafe Safety IV Catheter 18 Gauge x 1.16" | Green |
| MS-84420 | TrueSafe Safety IV Catheter 20 Gauge x 1.88" | Pink |
| MS-844202 | TrueSafe Safety IV Catheter 20 Gauge x 1.16" | Pink |
| MS-84422 | TrueSafe Safety IV Catheter 22 Gauge x 1.00" | Blue |
| MS-84424 | TrueSafe Safety IV Catheter 24 Gauge x 0.75" | Yellow |
| MS-84314 | TrueSafe Comfort Safety IV Catheter 14 Gauge x 1.75" | Orange |
| MS-84316 | TrueSafe Comfort Safety IV Catheter 16 Gauge x 1.77" | Gray |
| MS-84318 | TrueSafe Comfort Safety IV Catheter 18 Gauge x 1.88" | Green |
| MS-843182 | TrueSafe Comfort Safety IV Catheter 18 Gauge x 1.16" | Green |
| MS-84320 | TrueSafe Comfort Safety IV Catheter 20 Gauge x 1.88" | Pink |
| MS-843202 | TrueSafe Comfort Safety IV Catheter 20 Gauge x 1.16" | Pink |
| MS-84322 | TrueSafe Comfort Safety IV Catheter 22 Gauge x 1.00" | Blue |
| MS-84324 | TrueSafe Comfort Safety IV Catheter 24 Gauge x 0.75" | Yellow |
The device is available in six gauges identified also by specific colors.
Description of the Device Design:
The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort IV Safety Catheter are substantially equivalent to the MedSource Safety Catheter (K131555).
| Submission Device ↓ | Predicate Device ↓ | Comparison ↓ | |
|---|---|---|---|
| Comparison Point ↓ | MedSourceTrueSafe Safety IVCatheter andMedSourceTrueSafe ComfortSafety IV Catheter | MedSource IV SafetyCatheter (K131555) | |
| Technology | |||
| Mode of Operation | Aseptic technique,proper skinpreparation andcontinued protectionof the side areessential. ObserveUniversal Precautionson ALL patients. | Aseptic technique,proper skin preparationand continuedprotection of the sideare essential. ObserveUniversal Precautionson ALL patients. | Same |
| A. Remove needlecover in a straightoutward motion andinspect catheter unit.Rotate catheter 360°. | cover in a straightoutward motion andinspect catheter unit.Rotate catheter 360°. | ||
| B. Performvenipuncture. | B. Performvenipuncture. | ||
| C. Observe bloodreturn. Blood returnwill also be visiblethrough the catheter.Lower and advancecatheter unit 1/8". | C. Observe bloodreturn. Blood returnwill also be visiblethrough the catheter.Lower and advancecatheter unit 1/8". | ||
| D. Holding the flashchamber stationary,advance the catheteroff the needle into thevein. | D. Holding the flashchamber stationary,advance the catheter offthe needle into the vein. | ||
| E. Beforewithdrawing needlefrom the catheter,depress button toretract the needle intothe clear safetyshield.Immediately discardunit in a punctureresistant, leak proofsharps container.If needle retractiondoes not occur,depress button again.Dispose of anyunshielded needlesimmediately.Keep needlepointaway from body andfingers at all times.F. Connect tubing oradapter.G. Secure Catheter | E. Before withdrawingneedle from thecatheter, depress buttonto retract the needleinto the clear safetyshield.Immediately discardunit in a punctureresistant, leak proofsharps container.If needle retractiondoes not occur, depressbutton again. Disposeof any unshieldedneedles immediately.Keep needlepoint awayfrom body and fingersat all times.F. Connect tubing oradapter.G. Secure Catheter |
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| Distal Endconfiguration | Beveled | Beveled | Same |
|---|---|---|---|
| Proximal Endconfiguration | Cupper | Cupper | Same |
| Needle StickPrevention Feature | Push-button needleshielding | Push-button needleshielding | Same |
| Catheter LengthCatheter O.D.Needle Gauge | Gauge Length ODmm mm24G 19 0.722G 25 0.920G 25 1.118G 25 1.316G 30 1.714G 45 2.1 | Gauge Length ODmm mm24G 19 0.722G 25 0.920G 25 1.118G 25 1.316G 30 1.714G 45 2.1 | Same |
| SterilizationMethod | ETO | ETO | Same |
| Sterility AssuranceLevel (SAL) | 10-6 | 10-6 | Same |
| Shelf Life | 5 Years | 5 Years | Same |
| Materials | |||
| Catheter | PUR/PTFE | PUR/PTFE | Same |
| Needle | Stainless Steal | Stainless Steal | Same |
| Catheter Body | K-Resin | K-Resin | Same |
| Catheter Holder | Polyacetal (POM) | Polyacetal (POM) | Same |
| Needle Hub | K-Resin | K-Resin | Same |
| Activation Lever | Polyacetal (POM) | Polyacetal (POM) | Same |
| FlashbackChamber | ABS | ABS | Same |
| Hydrophobic Filter | Poly-ethylene | Poly-ethylene | Same |
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Differences to Predicate Device
The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter has a notched-needle design to allow for instant blood flash while inserting the needle. This gives the caregiver an instant indication of vein penetration. A push off tab was added to the catheter hub to allow for a more careful insertion on the catheter. The Needle cover was modified for a better fit on the device to eliminate unintended activations. The differences do not raise new questions of safety and effectiveness as the differences enhance the products features. The instant blood flash and the push off tab enhance the care giver experience and allow for better insertion and vein penetration.
Nonclinical Tests
Nonclinical Bench Performance testing was performed to show that the MedSource TrueSafe Safety IV Catheter meets the standards set forth in ISO 10555-1: Sterile, singleuse intravascular Catheter-General Requirements and ISO 10555-5: Sterile, single-use, intravascular Catheter-Over needle peripheral catheter.
| Test Performed | Criteria | Result |
|---|---|---|
| Needle Point | Free from foreign parts with no blunt needles or dents | Pass |
| Flow RateThroughCatheter | Flow rate should be 55ml/min | Pass |
| CorrosionResistance Test | There shall be no sign of corrosion | Pass |
| Method forDeterminingTensile Force atBreak | Minimum force at break shall be $≥ 5N$ | Pass |
| CatheterCollapseThroughAspiration Test | There shall be no ingress of air bubbles in to the syringe | Pass |
| Gauging Test | NO-GO side of the steel gauge should not be inside the luer. | Pass |
| Liquid LeakageFrom ConicalFitting AssemblyUnder Pressure | No liquid leakage should be there, when the assembly issubjected to withstand a pressure of 3.0 to 3.2 bar for 30sec. | Pass |
| Air Leakagefrom the ConicalFitting AssemblyDuring | There should be no air bubble formation from the assemblyup to 15sec. | Pass |
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| Aspiration | ||||
|---|---|---|---|---|
| Separation Forceof ConicalFitting Assembly | There should be no detachment while applying a force of 10newtons away from the fixture. | Pass | ||
| Stress Cracking | There should not be any sign if cracking in the device luerfitting | Pass | ||
| UnscrewingTorque of FittingAssembly | There shall be no separation when the fitting is tested | Pass | ||
| Ease ofAssembly | Male reference fitting should insert without any jerk and fittogether securely. | Pass | ||
| Resistance toOverriding | There shall not be any unusual damage on either of thefemale part or to the reference fitting. | Pass | ||
| Radiopacity ofCatheter | Visually compare the images of the test specimen to thebackground on the film. | Pass | ||
| CatheterElongationTesting | Measure the gauge length and tensile strength at break | Pass | ||
| CatheterStiffness Testing | As per manufacturer data, Shore: D-60 ± 4 | Pass | ||
| Resistance toDisinfection | No visual damage shall be present. As per ISO 527, thecatheter shall show no degradation in tensile properties.Catheter tube elongation should be greater than 100% ( as incontrol i.e., non-exposed samples) | Pass | ||
| Needle HubDetachmentForce | 20N when testing needles of nominal O.D ≥ 0.6 mm | Pass | ||
| Needle SafetyMechanismActivation Test | Check whether the activation Lever activated smoothlywithout any jerk and check the complete length of the needleenclose to the safety chamber. | Pass | ||
| VenipunctureProcess: NeedleStick | GAUGE | MAX PENETRATION LOAD(Newton) | MAX FRICTION(Newton) | Pass |
| 14 | 2.70N | 0.70N | ||
| 16 | 2.50N | 0.60N | ||
| 17 | 2.40N | 0.60N | ||
| 18 | 1.90N | 0.50N | ||
| 20 | 1.60N | 0.40N | ||
| 22 | 1.50N | 0.35N | ||
| 24 | 1.35N | 0.34N | ||
| 26 | 1.30N | 0.45N | ||
| VenipunctureProcess:TightnessBetweenCatheter Tube | The distance should not exceed maximum value of 1.0mmand should be greater than 0.1mm. | Pass |
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| and CannulaActivationTesting | That 97.5% of the time the failure rate would be no higherthan 0.7% and 99.5% confident that the failure rate is nothigher than 1.1%. | Pass |
|---|---|---|
| Biocompatibility | Sensitization Testing (Primary Skin Irritation)Standard ISO 10993 Part 10 | Pass |
| Biocompatibility | Intracutaneous Reactivity TestStandard 10993 Part 5 | Pass |
| Biocompatibility | In-Vitro CytotoxicityStandard ISO 10003 Part 5 | Pass |
| Biocompatibility | Systemic ToxicityStandard ISO 10993 Part 11 | Pass |
| Biocompatibility | Hemocompatibility TestStandard ISO 10993-1 | Pass |
Simulated Clinical Use Testing
500 units were tested, 0 units failed to activate the safety feature. Based on that, it can be determined that 97.5% of the time the failure rate would be no higher than 0.7% and 99.5% confident that the failure rate is not higher than 1.1%
Conclusion:
As shown by data in the table above, there are no significant performance specification differences between the MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter and the substantially equivalent device. Therefore, we conclude that the devices are substantially equivalent.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).