K Number

Device Name

MedSource ClearSafe Safety IV Catheter

Manufacturer

MedSource International

Date Cleared

2015-07-15

(127 days)

Product Code

FOZ

Regulation Number

880.5200

Intended Use

The MedSource ClearSafe Safety IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource ClearSafe 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.

Device Description

The MedSource ClearSafe Safety IV Catheter is a medical device used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. The device is equipped with a safety feature intended to prevent needle stick injuries. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids, and have hence been potentially contaminated with infectious agents. In addition this device also secures the needle (used to insert the catheter) in an enclosed chamber, thus protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded postuse. The MedSource ClearSafe Safety IV Catheter is 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 The components combine for an ergonomic design that incorporate a safety feature that when the device is withdrawn, the needle is completely enclosed within the chamber. The retraction mechanism is activated by the user using only one hand by means of a sliding motion. The device is available in six gauges identified also by specific colors.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K131555

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical components and a user-activated safety feature, with no mention of AI or ML.

Therapeutic

No
The device is described as a medical device for inserting a catheter to deliver or drain fluids, and its primary purpose relates to the administration or sampling of substances rather than providing a therapeutic effect itself.

Diagnostic

No
The device is used for administering or draining fluids, not for diagnosing conditions. Its primary function is therapeutic/interventional, with a safety feature for healthcare workers.

SaMD (Software as a Medical Device)

The device description explicitly lists multiple physical components (protective needle cover, catheter hub, catheter tube, etc.) and describes a mechanical safety feature, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the MedSource ClearSafe Safety IV Catheter is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to "sample blood or administer fluids intravenously." This describes a procedure performed directly on a patient's body for therapeutic or diagnostic purposes, not a test performed on a sample outside the body.
Device Description: The description focuses on the physical components and function of a catheter used for insertion into a vein, including a safety feature to prevent needle stick injuries. This aligns with a medical device used for direct patient care.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing a sample in vitro (in glass or outside the body).

Therefore, the MedSource ClearSafe Safety IV Catheter is a medical device used for intravenous access and fluid management, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FOZ

Device Description

The MedSource ClearSafe Safety IV Catheter is 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. The retraction mechanism is activated by the user using only one hand by means of a sliding motion.

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

any patient population

Intended User / Care Setting

healthcare workers

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)

Activation Testing:

Study type: Activation Testing
Sample size: 500 units of the MedSource ClearSafe Safety IV Catheter
Key results: 0 units failed to activate the safety feature. It can be determined there is no issue outside of the confidence interval as stated in the Clinical Simulation 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%).

Simulation Testing:

Study type: Clinical Simulation Testing
Sample size: Not specified (used a variety of Health Care Professionals)
Key results:
1. Is no more difficult to use then other similar devices
2. Is easy to activate and does not require extensive training
3. Does not interfere with normal use of the product.
4. Is required to be used when correctly operating the device
5. Eliminates the need for exposed needles in connections
6. Works well with a variety of hand sizes and under various, common uses (gloved, wet, dry hands)
7. Operates reliably- 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%
8. Exposed sharp is covered after use and prior to disposal.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Activation failure rate (confidence intervals): 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%.

Predicate Device(s)

K131555

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the department's role and national scope.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 15, 2015

MedSource International Ms. Laura Riggen Director, Quality and Regulatory Affairs 4201 Norex Drive Chaska, Minnesota 55318

Re: K150611

Trade/Device Name: MedSource ClearSafe Safety IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: II Product Code: FOZ Dated: June 5, 2015 Received: June 8, 2015

Dear Ms. 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.

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); 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K150611

Device Name MedSource ClearSafe Safety IV Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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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: Tuesday, July 14, 2015

General Information:

Regulatory Reference: 21 CFR §880.5200 Classification Name: Intravascular Catheter Product Code: FOZ Common Name: Catheter, intravascular, therapeutic, short-term Classification: Class II Panel: General Hospital Proprietary Name: MedSource ClearSafe Safety IV Catheter Single Use: Yes Sterile: Yes Predicate Device: K131555 MedSource IV Safety Catheter

Indication for Use:

Description of the Device:

The device is available in six gauges identified also by specific colors.

Part Number	Model Description	Color
MS-84114	MedSource ClearSafe Safety IV Catheter 14 Gauge	Orange
MS-84116	MedSource ClearSafe Safety IV Catheter 16 Gauge	Gray
MS-84118	MedSource ClearSafe Safety IV Catheter 18 Gauge	Green
MS-841182	MedSource ClearSafe Safety IV Catheter 18 Gauge	Green
MS-84120	MedSource ClearSafe Safety IV Catheter 20 Gauge	Pink
MS-841202	MedSource ClearSafe Safety IV Catheter 20 Gauge	Pink
MS-84122	MedSource ClearSafe Safety IV Catheter 22 Gauge	Blue
MS-84124	MedSource ClearSafe Safety IV Catheter 24 Gauge	Yellow

Predicate Device Comparison:

The MedSource ClearSafe Safety IV Catheter is substantially equivalent the MedSource Safety Catheter (K131555).

Section 1 Comparison of Technological Characteristics:

	Submission Device ↓	Predicate Device ↓	Comparison ↓
Comparison Point ↓	MedSource
ClearSafe Safety IV
Catheter (K150611)	MedSource IV Safety
Catheter (K131555)
	Technology
Distal End
configuration	Beveled	Beveled	Same
Proximal End
configuration	Cupper	Cupper	Same
Intended Use	The MedSource
ClearSafe Safety IV
Catheter is
indicated to sample
blood or administer
fluids
intravenously. The
MedSource
ClearSafe 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 IV
Safety Catheter is
indicated to sample
blood or administer
fluids intravenously.
The MedSource IV
Safety 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.	Same
Needle Stick
Prevention Feature	Sliding activation
needle
Shielding	Push-button needle
shielding	The safety feature
activation is different
but acts in the same
fashion.
Catheter Length
Catheter O.D.
Needle Gauge	Gauge Length OD
mm
mm
24G
0.7
19
22G
0.9
ટર્ટ
20G
ટર્ટ
1.1
18G
32
1.3
32
16G
1.7
14G
32
2.1	Gauge Length OD
mm
mm
24G
0.7
19
22G
25
0.9
20G
ટર્ટ
1.1
18G
ટર્ટ
1.3
16G
30
1.7
14G
2.1
તર	Same
Catheter	Materials
PUR/PTFE	PUR/PTFE	Same
Needle	Stainless Steel	Stainless Steel	Same
Catheter Body
K-Resin		K-Resin	Same
Catheter Holder	Polyacetal (POM)	Polyacetal (POM)	Same
Needle Hub
ABS		ABS	Same
Activation Lever	NA	Polyacetal (POM)	There is no
Activation lever on
			the Submission
Device.
Flashback
Chamber	ABS	ABS	Same
Hydrophobic Filter	Poly-ethylene	Poly-ethylene	Same

Section 2 Comparison of Non-Clinical Data:

Non Clinical Tests:

The following tests were performed to show that the MedSource ClearSafe Safety IV Catheter meets the standards set forth in ISO 10555-1: Sterile, single-use intravascular Catheter- General Requirements and ISO 10555-5: Sterile, single-use, intravascular Catheter-Over needle peripheral catheter.

Needle Point Geometry (Bevel)

Tested per ISO 10555-5:1996(E) Conclusion: Based on the test conditions contained in the Standard, the cannula is subsequently complying with the requirements of ISO 10555-1.

Gravity Flow

Determination of flow rate through catheter (using water 1, 000kg/m3) measure the efflux not less than 30s, express the average flow rate Tested per ISO10555-5:1996(E) Annex B Conclusion:

As per the test conditions contain herein, the flow rate observed from the catheter is under the specified limit 55 ml/min.

Corrosion Resistance Test

Tested per ISO10555-1:1995 Conclusion:

As per the test conditions contain herein, the cannula/needles are checked visually for signs of corrosion and the results are complies the condition as per EN ISO 10555-1.

Method for Determining Force at Break

(Hub-tube tensile test, strain rate: 20mm/min/mm. test speed: 400mm/min-min force at break 5N OD 0.75-1.15) Tested Per ISO10555-1:1995 Annex B. Conclusion: As per the test conditions contain herein, the observed value at break is under the specified limit. i.e. Average force at break - 22N.

Catheter Collapse

Air leakage during aspiration.(Visual inspection made for ingress of air bubbles to the syringe)

Tested per ISO10555-1 Annex D

Conclusion:

As per the test conditions contain herein, the whole assembly is checked for ingress of air bubbles and there was no air bubble formation observed from the hub assembly up to 30sec.

Gauging Test

Tested per ISO594/1-1986(E) Sec. 5.1 Conclusion: As per the test conditions contain herein, the catheter luer (body) is complies with the requirement of EN 20594-1 as per the steel gauge.

Liquid Leakage from the Conical Fitting Assembly under Pressure

Tested per ISO594/1-1986(E) Sec. 5.2 Conclusion:

As per the test conditions contain herein, there is no liquid leakage observed from the assembly at 3bar up to 15min.

Air Leakage from the Conical Fitting Assembly during Aspiration

Tested per EN 20594-1, ISO 10555-1 Annex D

Conclusion:

As per the test conditions contain herein, the whole assembly is checked for ingress of air bubbles and there was no air bubble formation observed from the hub assembly up to 30sec.

Liquid Leakage under Pressure

(300 to 320 kPa to be generated or 30s) Tested per EN 20594-1 Sec. 5.2. ISO 10555-5:1995(E) Annex C Conclusion:

As per the test conditions contain herein, there is no liquid observed from the assembly at 3bar up to 15min.

Separation Force of Conical Fitting Assembly

Tested per ISO594-1 Sec. 5.4 Conclusion: As per the test conditions contain herein, the average force 7.4N is observed for the separation of connection, which is under the specified limit.

Stress Cracking

Tested per ISO594-1 Sec. 5.5, ISO594-2:1998(E) Sec. 5.8 Conclusion: As per the test conditions contain herein, there is no sign of any stress or cracking on the device material as well as no leakage was observed from the conical fitting up to 1min.

Unscrewing Torgue of Fitting Assembly

Tested per ISO594-2:1998(E) Conclusion: As per the test conditions contain herein, the average force 0.06 Nm is observed to unscrew the male luer assembly from the female luer assembly.

Ease of Assembly

Tested Per ISO594-2:1998(E) Sec. 5.6 Conclusion: As per the test conditions contain herein, the male reference fitting inserts without any jerk and fits securely.

Resistance to Overriding

Tested Per ISO594-2:1998 (E) Sec. 5.7 Conclusion: As per the test conditions contain herein, there are no damage observed during the fitting of male reference fitting to the female luer.

Radiopacity of Catheter

Tested per ASTM F640-07 Test Result: Passed X- Ray image is as attached.

Image /page/8/Picture/10 description: The image is a blurry, out-of-focus shot of what appears to be a light source or reflection. The background is a muted gray, and the light source is a bright, diffused white. The light is stretched horizontally across the frame, creating a sense of movement or distortion.

Catheter Elongation Testing

(Determination of Elastic Modulus) Tested per ISO 527-1

Acceptance Criteria: The strength at break should be 25 N for the tube with outer diameter > 1. Conclusion: Passed

Catheter Flexural Fatigue

Strength Tolerance Tested per BS EN 13868:2002 Conclusion: As per the test conditions contain herein, average kink length observed is as above and there is no kink mark observed while the flow rate is observed