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.

Device Description

The MedSource IV Safety Catheter is a safety 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. 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 device comprises a sharp needle attached to a hub which projects into a chamber. In the 'unactivated' state prior to insertion, the needle and hub are 'locked' in position. There exists a retraction mechanism for 'unlocking' the needle such that on activation of this mechanism it is withdrawn and completely enclosed within the chamber. This mechanism for retracting the needle preferably includes a coiled spring or other elastic components. The retraction mechanism is activated by the user using only one hand by means of a lever or 'switch'.

AI/ML Overview

The provided text is a 510(k) Summary for the MedSource IV Safety Catheter, which is a medical device and not an AI/ML product. Therefore, many of the requested elements pertaining to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this document.

However, I can extract the acceptance criteria and performance data as presented for this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document performs a comparison to a predicate device (Becton Dickinson Angiocath Autogaurd, K984059) to demonstrate substantial equivalence. The "acceptance criteria" for the MedSource IV Safety Catheter are implied by its performance being equivalent to or better than the predicate device's established performance, as well as compliance with specific ISO and ASTM standards.

Comparison Point	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (MedSource IV Safety Catheter)
Chemical Tests
Volatile Residue	<15.0mg	<15.0mg
Heavy Metals	<1ppm	<1ppm
Residue on Ignition	<5.0mg	<5.0mg
Buffering Capacity	Complies to USP-34	Complies to USP-34
Biological Tests
Sterility	Sterile ETO	Sterile ETO
Physical Tests
Integrity	Complies to ISO 10555-1 and ISO10555-5	Complies to ISO 10555-1 and ISO10555-5
Flow-rate
14G	300 ml/min	300 ml/min
16G	220 ml/min	220 ml/min
18G	105 ml/min	105 ml/min
20G	65ml/min	65ml/min
22G	35ml/min	35ml/min
24G	20ml/min	20ml/min
Tensile Strength
18G	10N	10N
20G	5N	5N
22G	5N	5N
24G	3N	3N

2. Sample size used for the test set and the data provenance: Not applicable. This summary presents comparative performance data against a predicate device rather than a study on a specific test set for an AI/ML algorithm. The data reflects device specifications and compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document pertains to the physical and chemical properties and performance of a medical device, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth.

4. Adjudication method for the test set: Not applicable (see point 3).

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: Not applicable. This is a traditional medical device, not an AI/ML product involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document describes a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is established by compliance with international standards (ISO, USP, ASTM) and direct comparison to the specifications of a legally marketed predicate device. For example, "Sterile ETO" is a factual characteristic, and "Complies to USP-34" refers to a specific standard.

8. The sample size for the training set: Not applicable. This is a traditional medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable (see point 8).

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is detailed within the "Summary of Performance Testing Characteristics" section. This study involved direct comparison testing of the MedSource IV Safety Catheter against the established specifications and performance of its predicate device, the Becton Dickinson Angiocath Autogaurd (K984059).

The testing covered:

Chemical Tests: Volatile Residue, Heavy Metals, Residue on Ignition, and Buffering Capacity. The results showed identical performance to the predicate device, meeting the specified limits (e.g., <15.0mg for volatile residue, <1ppm for heavy metals, complies to USP-34).
Biological Tests: Sterility. Both the submission device and predicate demonstrated "Sterile ETO."
Physical Tests: Integrity (compliance to ISO 10555-1 and ISO10555-5), Flow-rate for various gauges, and Tensile strength for various gauges. For all these physical tests, the MedSource IV Safety Catheter exhibited performance metrics identical to those reported for the predicate device.

The study concludes that "there are no significant performance specification differences between the MedSource IV Safety Catheter and the substantially equivalent device," leading to the determination that it is as safe, as effective, and performs as well as or better than the predicate device. The reference documents listed (ISO, ASTM, USP standards) indicate the methods and criteria against which these tests were conducted to demonstrate compliance and equivalence.

Summary

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KISISSE

JAN 3 1 2014

510(K) Summary

Section 5

Medsource International, LLC Submitter: 5346 Shoreline Drive Mound, MN 55364

Contact Person: Jennifer Ness, Quality and Regulatory Affairs Manager 5346 Shoreline Drive Mound, MN 55364 Phone: 952-241-8318

Date Prepared: Wednesday, November 06, 2013

General Information:

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

Indication for Use:

Description of the Device:

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mechanism for retracting the needle preferably includes a coiled spring or other elastic components. The retraction mechanism is activated by the user using only one hand by means of a lever or 'switch'.

Model	Description	Gage	Color
MS-84014	IV SAFETY CATHETER: 14 GA X 1.75"(50/BX)	14	Orange
MS-84016	IV SAFETY CATHETER: 16 GA X 1.16"(50/BX)	16	Gray
MS-84018	IV SAFETY CATHETER: 18 GA X 1.16"(50/BX)	18	Green
MS-84020	IV SAFETY CATHETER: 20 GA X 1.16" (50/BX)	20	Pink
MS-84022	IV SAFETY CATHETER: 22 GA X 1"(50/BX)	22	Blue
MS-84024	IV SAFETY CATHETER: 24 GA X .75" (50/BX)	24	Yellow

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

Description of the Device Design:

The MedSource IV Safety Catheter is substantially equivalent to the Becton Dickinson Angiocath Autogaurd (K984059)

Comparison Point	Predicate Devices	Result of Comparison
Intended Use	Becton Dickinson AngiocathAutogaud (K984059)	Substantially equivalent
TechnologicalCharacteristics(Materials ofConstruction,Dimensions,Performance in)	Becton Dickinson AngiocathAutogaud (K984059)	Materials of construction-sameor similarPerformance-minor variationsDimensions-minor variations
Instructions for Use	Becton Dickinson AngiocathAutogaud (K984059)	Very similar

Summary of Performance Testing Characteristics:

	Submission Device ↓	Predicate Device ↓
Comparison Point	MedSource IV Safety Catheter	Becton Dickinson AngiocathAutogaurd (K984059)
Chemical Tests
Volatile Residue	<15.0mg	<15.0mg
Heavy Metals	<1ppm	<1ppm
Residue on Ignition	<5.0mg	<5.0mg
Buffering Capacity	Complies to USP-34	Complies to USP-34
Biological Tests

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Sterility	Sterile ETO	Sterile ETO
	Physical Tests
Integrity	Complies to ISO 10555-1 andISO10555-5	Complies to ISO 10555-1 andISO10555-5

Flow-rate	14G: 300 ml/min16G: 220 ml/min18G: 105 ml/min20G: 65ml/min22G: 35ml/min24G: 20ml/min	14G: 300 ml/min16G: 220 ml/min18G: 105 ml/min20G: 65ml/min22G: 35ml/min24G: 20ml/min





Tensile	18G: 10N20G: 5N22G: 5N24G: 3N	18G: 10N20G: 5N22G: 5N24G: 3N

Conclusion:

As shown by data in the table above, there are no significant performance specification differences between the MedSource IV Safety Catheter and the substantially equivalent device. Therefore, we conclude that the performance specifications demonstrate that the Subject Device is as safe, as effective, and performs as well as or better than that of the legally marketed predicate device.

Reference Documents:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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January 31, 2014

MedSource International, LLC Ms. Jennifer Ness Manager, Quality Control and Regulatory Affairs 5346 Shoreline Drive Mound, MN 55318

Re: K131555

Trade/Device Name: MedSource IV Safety Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: May 23, 2013 Received: December 16, 2013

Dear Ms. Ness:

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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Page 2 - Ms. Ness

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely vours.

http://www.fda.gov/MedicalDevices/KResourcecenter/YourIndustry/default.htm.

Kwame O.
Ulmer-S

for

Erin I. Keith, M.S. 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 Statement SECTION 4

510(k) Number: K131555

Device Common Name: Catheter, intravascular, therapeutic, short-term Device Proprietary Name: MedSource IV Safety Catheter

Indications for Use: 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.

Prescription Usa (Part 21 CFR 601 Subpert D)

AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Digitally signed by Richard C. Chapman Date: 2014.01.30 13:53:08 -05'00'

FDA 510k Submission: MedSource IV Safely Catheter

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).