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 The components combine for an ergonomic design that incorporate a safety feature that when the device is withdrawn, the needle is completely enclosed within the chamber.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.

AI/ML Overview

The provided text describes the MedSource ClearSafe Safety IV Catheter and its non-clinical testing to demonstrate substantial equivalence to a predicate device (MedSource IV Safety Catheter, K131555). It does not contain information about a study involving AI, human readers, or a training dataset. The studies described are primarily performance tests against international standards for medical devices.

Here's the information extracted from the document based on your request, structured to address as many points as possible, even if the answer is "not applicable" or "not provided" given the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (from standard or internal spec)	Reported Device Performance
Needle Point Geometry (Bevel)	Per ISO 10555-5:1996(E) and ISO 10555-1 requirements.	Complies with the requirements of ISO 10555-1.
Gravity Flow	Flow rate not less than 30 seconds. Specific limit (55 ml/min) mentioned for observed rate.	Flow rate observed is under the specified limit (55 ml/min). (Note: There seems to be a slight discrepancy in phrasing between "not less than 30s" and the 55 ml/min limit.)
Corrosion Resistance Test	Per ISO10555-1:1995. Visual inspection for signs of corrosion.	Cannula/needles checked visually for signs of corrosion and results comply with EN ISO 10555-1.
Method for Determining Force at Break (Hub-tube tensile test)	Force at break 5N OD 0.75-1.15 (Specified limit).	Average force at break - 22N (under the specified limit).
Catheter Collapse (Air leakage during aspiration)	No ingress of air bubbles to the syringe (visual inspection).	No air bubble formation observed from the hub assembly up to 30s.
Gauging Test	Complies with the requirement of EN 20594-1 as per steel gauge.	Catheter luer (body) complies with the requirement of EN 20594-1.
Liquid Leakage from Conical Fitting Assembly under Pressure	No liquid leakage observed from the assembly at 3 bar up to 15 min.	No liquid leakage observed from the assembly at 3 bar up to 15 min.
Air Leakage from Conical Fitting Assembly during Aspiration	No ingress of air bubbles.	No air bubble formation observed from the hub assembly up to 30s.
Liquid Leakage under Pressure	No liquid observed from the assembly at 3 bar up to 15 min.	No liquid observed from the assembly at 3 bar up to 15 min.
Separation Force of Conical Fitting Assembly	Under the specified limit (not explicitly stated, but 7.4N is reported).	Average force 7.4N observed for the separation of connection, which is under the specified limit.
Stress Cracking	No sign of any stress or cracking on the device material; no leakage from conical fitting up to 1 min.	No sign of any stress or cracking on the device material as well as no leakage was observed from the conical fitting up to 1 min.
Unscrewing Torque of Fitting Assembly	(Not explicitly stated, but 0.06 Nm is reported as acceptable)	Average force 0.06 Nm observed to unscrew the male luer assembly from the female luer assembly.
Ease of Assembly	Male reference fitting inserts without any jerk and fits securely.	Male reference fitting inserts without any jerk and fits securely.
Resistance to Overriding	No damage observed during the fitting of male reference fitting to the female luer.	No damage observed during the fitting of male reference fitting to the female luer.
Radiopacity of Catheter	Passed (implicitly refers to ASTM F640-07 standard).	Passed. X-Ray image is attached (not provided in text).
Catheter Elongation Testing	Strength at break should be 25 N for the tube with outer diameter > 1.	Passed.
Catheter Flexural Fatigue Strength Tolerance	Average kink length as observed (not explicitly stated); no kink mark observed while flow rate is <50% from straight tube.	Average kink length observed is as above (not explicitly stated); no kink mark observed while the flow rate is observed <50% from the straight tube.
Catheter Stiffness (Durometer)	Complies with the hardness property of the material.	Value observed complies with the hardness property of the material.
Resistance to Disinfection	No damage observed during visual inspection of the catheter after exposure to disinfectants.	No damage observed during the visual inspection of the catheter.
Activation Testing (Safety Feature)	Failure rate no higher than 0.7% with 97.5% confidence; failure rate no higher than 1.1% with 99.5% confidence.	0 units failed to activate (out of 500 tested). 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%.
Clinical Simulation Testing	Easy to activate, not difficult to use, does not interfere with normal use, eliminates exposed needles, works with various hand sizes, operates reliably, exposed sharp covered after use.	Is no more difficult to use than other similar devices.Is easy to activate and does not require extensive training.Does not interfere with normal use of the product.Is required to be used when correctly operating the device.Eliminates the need for exposed needles in connections.Works well with a variety of hand sizes and under various, common uses.Operates reliably (0 units failed to activate the safety feature).Exposed sharp is covered after use and prior to disposal.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Non-Clinical Tests (e.g., Corrosion, Flow Rate): The document does not explicitly state the sample size for each individual non-clinical test. It generally refers to "the test conditions contain herein" and "cannula/needles are checked."
Activation Testing: 500 units of the MedSource ClearSafe Safety IV Catheter were tested (test set sample size = 500).
Clinical Simulation Testing: The test was conducted using a "variety of Health Care Professionals." The exact number is not specified but the conclusion relates to the 500 units observed in the Activation Testing.
Data Provenance: Not specified, but given the submission is to the US FDA, the tests were conducted for market clearance in the USA. It's a prospective testing process specifically for device clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Experts: For the "Clinical Simulation Testing," unspecified "Health Care Professionals" were used as participants. Their qualifications (e.g., specific clinical roles, years of experience) are not provided. They were users of the device rather than traditional "experts" establishing a ground truth in a diagnostic sense.
Ground Truth Establishment: For the technical performance tests, the "ground truth" is defined by the compliance with the referenced ISO/ASTM standards (e.g., a certain force at break, no leakage). For the safety feature activation and simulation testing, the "ground truth" is the observed functionality and user feedback on ease of use and reliability.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable or not specified. These are primarily performance and functionality tests against predefined criteria or direct observations (e.g., 0 failures in 500 activations). There's no indication of multiple reviewers adjudicating outcomes as one might see in a diagnostic study.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This document describes a medical device (an IV catheter) primarily undergoing non-clinical technical performance testing and a simulation test for its safety feature. It does not involve AI, image interpretation, or diagnostic decision-making by human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Study: No, this does not apply. The device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth:
- For the non-clinical performance tests (e.g., flow rate, tensile strength, corrosion, leakage), the ground truth is defined by the specific requirements and methodologies of the referenced international standards (ISO, ASTM, EN). The device's performance is compared against these engineering and material science specifications.
- For the "Activation Testing" and "Clinical Simulation Testing" of the safety feature, the ground truth is direct, observable functionality and user feedback related to the device's mechanism and ease of use. "0 failures to activate" is a direct observational ground truth.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This document describes a medical device undergoing pre-market clearance testing, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Training Set Ground Truth: Not applicable, as there is no training set for an AI algorithm.

Summary

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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.

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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 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

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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)

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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:

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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 ↓	MedSourceClearSafe Safety IVCatheter (K150611)	MedSource IV SafetyCatheter (K131555)
	Technology
Distal Endconfiguration	Beveled	Beveled	Same
Proximal Endconfiguration	Cupper	Cupper	Same
Intended Use	The MedSourceClearSafe Safety IVCatheter isindicated to sampleblood or administerfluidsintravenously. TheMedSourceClearSafe Safety IVCatheter may beused for any patientpopulation withconsideration givento adequacy for thevascular anatomyappropriateness forthe solution beingadministered andduration of thetherapy.	The MedSource IVSafety Catheter isindicated to sampleblood or administerfluids intravenously.The MedSource IVSafety Catheter maybe used for anypatient populationwith considerationgiven to adequacy forthe vascular anatomyappropriateness forthe solution beingadministered andduration of thetherapy.	Same
Needle StickPrevention Feature	Sliding activationneedleShielding	Push-button needleshielding	The safety featureactivation is differentbut acts in the samefashion.
Catheter LengthCatheter O.D.Needle Gauge	Gauge Length ODmmmm24G0.71922G0.9ટર્ટ20Gટર્ટ1.118G321.33216G1.714G322.1	Gauge Length ODmmmm24G0.71922G250.920Gટર્ટ1.118Gટર્ટ1.316G301.714G2.1તર	Same
Catheter	MaterialsPUR/PTFE	PUR/PTFE	Same
Needle	Stainless Steel	Stainless Steel	Same
Catheter BodyK-Resin		K-Resin	Same
Catheter Holder	Polyacetal (POM)	Polyacetal (POM)	Same
Needle HubABS		ABS	Same
Activation Lever	NA	Polyacetal (POM)	There is noActivation lever on
			the SubmissionDevice.
FlashbackChamber	ABS	ABS	Same
Hydrophobic Filter	Poly-ethylene	Poly-ethylene	Same

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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.

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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.

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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

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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 <50% from the straight tube.

Catheter Stiffness

(Durometer) Tested per ASTM D2240-05:2010 (R) Conclusion: As per the test conditions contain herein, the value observed is complies the hardness property of the material.

Resistance to Disinfection

(1-Alcohol 70%, 2- Mixture of Povidone Iodine 10%, 3-Chlorhexidine Gluconate 0.5%) Conclusion:

As per the test conditions contain herein, there is no damage observed during the visual inspection of the catheter.

Activation Testing:

Activation Testing was completed on the MedSource ClearSafe Safety IV Catheter. 500 Units of the MedSource ClearSafe Safety IV Catheter were obtained. Each unit was opened and the safety feature was activated and observed, making note of any deviation and the success or failure of the anti-needle stick feature. Failure is defined as a needle stick injury or a significant problem with the safety feature that may lead to an injury.

Testing was completed on April 7, 2014 in 5 Test Cycles of 100.

Conclusion of Activation Testing:

Out of the 500 MedSource ClearSafe Safety IV Catheters that were tested, 0 units failed to activate the safety feature. Based on that, 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

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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:

Clinical Simulation Testing was completed over the course of April 15 -- April 9th, 2015 for the MedSource ClearSafe Safety IV Catheter. The test was conducted using a variety of Health Care Professionals.

Each participant was able to use the MedSource ClearSafe Safety IV Catheter with little instruction and had no issues being able to activate the safety feature.

Conclusion of Simulation Testing:

Based on the results of the Safety Feature Evaluation form it can be determined that the Medsource ClearSafe Safety IV Catheter's safety feature:

1. Is no more difficult to use then other similar devices
1. Is easy to activate and does not require extensive training
1. Does not interfere with normal use of the product.
1. Is required to be used when correctly operating the device
1. Eliminates the need for exposed needles in connections
Works well with a variety of hand sizes and under various, common uses 6. (gloved, wet, dry hands)
1. 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%
1. Exposed sharp is covered after use and prior to disposal.

Conformity to the Following Recognized Standards:

1. ISO 10555-5: Sterile, single use intravascular catheters
1. ISO 11607-1/2 Packaging for terminally sterilized medical devices
1. BS EN 868-5 Packaging materials and systems for medical devices which are to be sterilized. Heat and self-sealable pouches and reels of paper and plastic film construction-Requirements and test methods
1. DIN 58953-6 "Sterilization paper for bags and tubing pickings ".Testing for germ proof ness in moisture with passage of air
1. ASTM F 2054 Standard test method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization within Restraining Plates.
1. ASTM F 1980-02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
1. ASTM D638 Plastic Tensile Testing

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1. ISO 10993: Part 10 Biological evaluation of medical devices: Test of irritation and skin sensitization.

Conclusion:

As shown by data in the table above, there are no significant performance specification differences between the MedSource ClearSafe Safety IV Catheter and the predicate device. Testing was done to confirm the adequate performance of the device and safety feature. Therefore, we conclude that the performance specifications demonstrate that the subject device is substantially equivalent to the legally marketed predicate device.

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).