(127 days)
No
The description focuses on mechanical components and a safety retraction mechanism, with no mention of AI or ML.
No.
This device is an IV catheter used for administering or sampling fluids, not for treating a disease or condition itself.
No
The device is an IV catheter used for administering or sampling fluids, not for diagnosing conditions.
No
The device description clearly lists multiple physical components (protective needle cover, catheter hub, catheter tube, etc.) and describes a mechanical safety feature, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "sample blood or administer fluids intravenously." This describes a procedure performed on the patient's body, not a test performed on a sample of the patient's body fluid outside the body.
- Device Description: The description details a device for inserting a catheter into a patient's body for fluid delivery or drainage. This is a medical device used for treatment or diagnosis in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing a sample, using reagents, or performing a test to diagnose a condition based on a sample.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device is clearly used in vivo (within the body).
N/A
Intended Use / Indications for Use
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.
Product codes
FOZ
Device Description
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.
The device is available in six gauges identified also by specific colors.
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
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.
Intended User / Care Setting
Not Found
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)
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.
Simulated Clinical Use Testing: 500 units were tested, 0 units failed to activate the safety feature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Based on the simulated clinical use testing, 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%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
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 (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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
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.
4
| 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 ↓ | MedSource | ||
| TrueSafe Safety IV | |||
| Catheter and | |||
| MedSource | |||
| TrueSafe Comfort | |||
| Safety IV Catheter | MedSource IV Safety | ||
| Catheter (K131555) | |||
| Technology | |||
| Mode of Operation | Aseptic technique, | ||
| proper skin | |||
| preparation and | |||
| continued protection | |||
| of the side are | |||
| essential. Observe | |||
| Universal Precautions | |||
| on ALL patients. | Aseptic technique, | ||
| proper skin preparation | |||
| and continued | |||
| protection of the side | |||
| are essential. Observe | |||
| Universal Precautions | |||
| on ALL patients. | Same | ||
| A. Remove needle | |||
| cover in a straight | |||
| outward motion and | |||
| inspect catheter unit. | |||
| Rotate catheter 360°. | cover in a straight | ||
| outward motion and | |||
| inspect catheter unit. | |||
| Rotate catheter 360°. | |||
| B. Perform | |||
| venipuncture. | B. Perform | ||
| venipuncture. | |||
| C. Observe blood | |||
| return. Blood return | |||
| will also be visible | |||
| through the catheter. | |||
| Lower and advance | |||
| catheter unit 1/8". | C. Observe blood | ||
| return. Blood return | |||
| will also be visible | |||
| through the catheter. | |||
| Lower and advance | |||
| catheter unit 1/8". | |||
| D. Holding the flash | |||
| chamber stationary, | |||
| advance the catheter | |||
| off the needle into the | |||
| vein. | D. Holding the flash | ||
| chamber stationary, | |||
| advance the catheter off | |||
| the needle into the vein. | |||
| E. Before | |||
| withdrawing needle | |||
| from the catheter, | |||
| depress button to | |||
| retract the needle into | |||
| the clear safety | |||
| shield. | |||
| Immediately discard | |||
| unit in a puncture | |||
| resistant, leak proof | |||
| sharps container. | |||
| If needle retraction | |||
| does not occur, | |||
| depress button again. | |||
| Dispose of any | |||
| unshielded needles | |||
| immediately. | |||
| Keep needlepoint | |||
| away from body and | |||
| fingers at all times. | |||
| F. Connect tubing or | |||
| adapter. | |||
| G. Secure Catheter | E. Before withdrawing | ||
| needle from the | |||
| catheter, depress button | |||
| to retract the needle | |||
| into the clear safety | |||
| shield. | |||
| Immediately discard | |||
| unit in a puncture | |||
| resistant, leak proof | |||
| sharps container. | |||
| If needle retraction | |||
| does not occur, depress | |||
| button again. Dispose | |||
| of any unshielded | |||
| needles immediately. | |||
| Keep needlepoint away | |||
| from body and fingers | |||
| at all times. | |||
| F. Connect tubing or | |||
| adapter. | |||
| G. Secure Catheter |
5
6
| Distal End
| configuration | Beveled | Beveled | Same |
|---|---|---|---|
| Proximal End | |||
| configuration | Cupper | Cupper | Same |
| Needle Stick | |||
| Prevention Feature | Push-button needle | ||
| shielding | Push-button needle | ||
| shielding | Same | ||
| Catheter Length | |||
| Catheter O.D. | |||
| Needle Gauge | Gauge Length OD | ||
| mm mm | |||
| 24G 19 0.7 | |||
| 22G 25 0.9 | |||
| 20G 25 1.1 | |||
| 18G 25 1.3 | |||
| 16G 30 1.7 | |||
| 14G 45 2.1 | Gauge Length OD | ||
| mm mm | |||
| 24G 19 0.7 | |||
| 22G 25 0.9 | |||
| 20G 25 1.1 | |||
| 18G 25 1.3 | |||
| 16G 30 1.7 | |||
| 14G 45 2.1 | Same | ||
| Sterilization | |||
| Method | ETO | ETO | Same |
| Sterility Assurance | |||
| Level (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 |
| Flashback | |||
| Chamber | ABS | ABS | Same |
| Hydrophobic Filter | Poly-ethylene | Poly-ethylene | Same |
7
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 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 $≥ 5N$ | Pass |
| Catheter | ||
| Collapse | ||
| Through | ||
| Aspiration 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 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 | There should be no air bubble formation from the assembly | |
| up to 15sec. | Pass |
8
| Aspiration | ||||
|---|---|---|---|---|
| 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 if 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 ≥ 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 | 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 | ||
| Venipuncture | ||||
| Process: | ||||
| Tightness | ||||
| Between | ||||
| Catheter Tube | The distance should not exceed maximum value of 1.0mm | |||
| and should be greater than 0.1mm. | Pass |
9
| and Cannula
Activation
Testing | 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%. | Pass |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------|
| Biocompatibility | Sensitization Testing (Primary Skin Irritation)
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 |
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.