The MedSource CathMed IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource CathMED 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 CathMED IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource CathMED 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.

Each MedSource CathMED IV Catheter is comprised of the following components: protective needle cover, color-coded catheter hub, radiopaque catheter tube, Teflon catheter holder, needle guide, medical grade stainless steel needle hub, porous plug and gauge chamber. The MedSource CathMED IV Catheter components combine for an ergonomic design.

The device inserts a catheter intravenously by inserting a sharp needle with an over-theneedle catheter. Once the needle and catheter have been passed into a vein the catheter can be advance off the needle is the needle is removed while the catheter remains in the vein for short term use to sample blood or administer fluids.

The MedSource CathMED IV Catheter gauges are color coded for positive identification and range from 14G to 24G

ORANGE = 14G GREY = 16G GREEN = 18G PINK = 20G BLUE = 22G YELLOW = 24G

AI/ML Overview

This looks like a 510(k) summary for a medical device called the MedSource CathMED IV Catheter. The document asserts substantial equivalence to a predicate device (MedSource IV Safety Catheter, K131555).

Based on the provided text, the device itself (MedSource CathMED IV Catheter) is an intravascular catheter, not an AI/ML powered device. As such, the typical acceptance criteria and study designs for AI/ML devices (e.g., sample size for test set, number of experts for ground truth, MRMC studies) are not applicable to this document. The document focuses on performance testing and biocompatibility for a physical medical device.

Therefore, I cannot directly provide the information requested in your prompt as it pertains to AI/ML device testing criteria. However, I can extract the relevant performance data and study information as presented for this physical medical device.

Here's what can be extracted from the document regarding the device's performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance standards and general requirements for intravascular catheters. It doesn't present specific quantitative acceptance criteria with corresponding performance data in a tabular format as would be expected for an AI/ML device. Instead, it indicates compliance with recognized standards.

Acceptance Criteria Category	Standard/Requirement	Reported Device Performance
Functional Performance	ISO 10555-5: Intravascular catheters Sterile and single-use catheters Part 5: Over-needle peripheral catheters	Assumed to meet requirements of this standard (implicit)
	ISO 10555-1 Intravascular catheters Sterile and single-use catheters Part 1: General requirements	Assumed to meet requirements of this standard (implicit)
Connections	ISO 594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. - Part 1: General requirements	Assumed to meet requirements of this standard (implicit)
	ISO 594-2 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings	Assumed to meet requirements of this standard (implicit)
Biocompatibility	No explicit standard mentioned for testing, but referenced predicate's testing.	"No changes to the material that impacted the biocompatibility of the device. A signed statement of conformance was included..."
Particulate Matter	USP <788> Particulate Matter in Injections	Assumed to meet requirements of this standard (implicit)
Sterility	ISO 11135:2014 Sterilization of health-care products Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices	Assumed to meet requirements of this standard (implicit)

2. Sample size used for the test set and the data provenance: Not applicable for this type of device and submission. The tests are for physical properties and materials, not for diagnostic accuracy on a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing typically refers to objective measurements against established engineering and material standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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, as this is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical performance testing, the "ground truth" would be the objective measurement results conforming to the specifications outlined in the referenced ISO and USP standards. For biocompatibility, it's a conformance statement based on the predicate device's testing.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary of the study conducted (as per the document):

The marketing clearance for the MedSource CathMED IV Catheter is based on a substantial equivalence determination to a legally marketed predicate device (MedSource IV Safety Catheter, K131555). The study essentially involved comparison and performance testing to demonstrate that the new device shares similar technological characteristics, indications for use, and performs equivalently to the predicate.

Key aspects of the "study" for this physical device include:

Comparison Table: A detailed comparison of the new device and the predicate in terms of technology, indications for use, design (distal/proximal end configuration, catheter length/OD/needle gauge), sterilization method, and materials.
Performance Testing: Declaration of compliance with various ISO standards related to intravascular catheters (ISO 10555-5, ISO 10555-1, ISO 594-1, ISO 594-2), as well as USP <788> for particulate matter. These tests would involve physical and mechanical evaluations of the device's properties.
Biocompatibility: A statement of conformance, indicating that because there were no material changes, the biocompatibility testing from the predicate device was leveraged. This implies the materials used in the new device are known to be biocompatible based on prior testing of the predicate.
Sterility: Conformance to ISO 11135:2014 for ethylene oxide sterilization.

The conclusion states that "based on the indication for use, technological characteristics and performance testing, the differences between the MedSource CathMED IV Catheter and the predicate did not raise concern for safety and effectiveness." This indicates that the performed testing implicitly demonstrated that the device met the requirements of the standards, thus proving its substantial equivalence.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 7, 2020

MedSource Labs Emilie Andrews Quality Technician 8600 Shelby Court Chanhassen, MN 55317

Re: K193278

Trade/Device Name: MedSource CathMED IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: July 13, 2020 Received: July 13, 2020

Dear Emilie Andrews:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Payal Patel Assistant Director, General Hospital DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193278

Device Name MedSource CathMED IV Catheter

Indications for Use (Describe)

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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510 K-Summary- K193278

Date of Prepared: August 6, 2020

A. Submitter:

MedSource International, LLC 8600 Shelby Court Chanhassen, MN 55317

B. Contact Person:

Emilie Andrews, Quality and Regulatory Affairs 8600 Shelby Court Chanhassen. MN 55317 Phone: 952-472-0131

C. Proposed Device:

Product Code: FOZ Trade Name: MedSource CathMED IV Catheter Common Name: Intravascular catheter Classification Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Regulatory Reference: 21 CFR §880.5200 Review Panel: General Hospital Classification: Class II

D. Predicate:

510(K): K131555 Product Code: FOZ Trade Name: MedSource IV Safety Catheter Common Name: Intravascular catheter Classification Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30Days Regulatory Reference: 21 CFR §880.5200 Review Panel: General Hospital Classification: Class II

E. Indications for Use:

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F. Device Description:

The MedSource CathMED IV Catheter gauges are color coded for positive identification and range from 14G to 24G

ORANGE = 14G GREY = 16G GREEN = 18G PINK = 20G BLUE = 22G YELLOW = 24G

G. SUMMARY OF COMPARISON TABLE OF PROPOSED DEVICE and PREDICATE

The proposed device is substantially equivalent to the predicate device the MedSource Safety Catheter (K131555).

ComparisonPoint	Submission DeviceMedSource CathMED IVCatheter	Predicate DeviceMedSource IV SafetyCatheter (K131555)	Discussion	Comments
Technology
Indications forUse	The MedSourceCathMED IV Catheter isindicated to sample bloodor administer fluidsintravenously. TheMedSource IV Cathetermay be used for anypatient population withconsideration given toadequacy for the vascularanatomy appropriatenessfor the solution beingadministered and	The MedSource IV SafetyCatheter is indicated tosample blood or administerfluidsintravenously. TheMedSource IV SafetyCatheter may be used forany patient populationwith consideration given toadequacy for the vascularanatomy appropriatenessfor thesolution being	Same
	duration of the therapy.	administered and durationof the therapy.
Intended Use	The MedSourceCathMED IV Catheter isindicated to sample bloodor administer fluidsintravenously. TheMedSource CathMED IVCatheter may be used forany patient populationwith consideration givento adequacy for thevascular anatomyappropriateness for thesolution beingadministered andduration of the therapy.	The MedSource IV SafetyCatheter is indicated tosample blood or administerfluids intravenously. TheMedSource IV SafetyCatheter may be used forany patient population withconsideration given toadequacy for the vascularanatomy appropriatenessfor the solution beingadministered and durationof the therapy.	Same
Distal Endconfiguration	Beveled	Beveled	Same
Proximal Endconfiguration	Cupper	Cupper	Same
Needle StickPreventionFeature	Not present	Push-button needleshielding	Different	Absent in thesubmissiondevice.A warning wasadded to thelabeling of thisproduct that aNeedle StickPreventionFeature is notpresent in thisdevice.This does notaffect the safetyandeffectiveness ofthe device.
CatheterLengthCatheter O.D.Needle Gauge	Gauge Length ODmm mm	Gauge Length ODmm mm	Different	one new GaugeLength "20Glength 33 mmOD 1.1 mm"
	24G	19	0.7
	24G	19	0.7
	22G	25	0.9
	22G	25	0.9
	20G 33 1.120G 25 1.118G 45 1.316G 45 1.814G 45 2.1	20G 25 1.118G 25 1.316G 30 1.714G 45 2.1	Same	added to thesubmissiondevice.This was addedto expand thesize availabilityfor patient care.This does notaffect the safetyandeffectiveness ofthe device.
Sterilization	Terminal Ethylene Oxide(EtO gas)	Terminal Ethylene Oxide(EtO gas)	Same
	Materials
Catheter	Polyurethane (PUR)/ (PTFE)Polytetrafluoroethylene	Polyurethane (PUR)/ (PTFE)Polytetrafluoroethylene	Same
Needle	Stainless Steel	Stainless Steel	Same
Catheter Body	K-Resin	K-Resin	Same
CatheterHolder	Polyacetal (POM)	Polyacetal (POM)	Same
Needle Hub	K-Resin	K-Resin	Same
ActivationLever	Absent	Polyacetal (POM)	Different	Absent in thesubmissiondevice.A warning wasadded to thelabeling of thisproduct that aNeedle StickPreventionFeature is notpresent in thisdevice.This does notaffect the safetyandeffectiveness of
				the device.
FlashbackChamber	PUR/PTFE	PUR/PTFE	Same
HydrophobicFilter	Stainless Steel	Stainless Steel	Same
Materials	K-Resin	K-Resin	Same
Sterilizationmethod	EtO	EtO	Same

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H. Performance Data:

I. Performance Testing:

ISO 10555-5: Intravascular catheters Sterile and single-use catheters Part 5: ● Over-needle peripheral catheters
ISO 10555-1 Intravascular catheters Sterile and single-use catheters Part 1: ● General requirements
ISO 594-1Conical fittings with a 6% (Luer) taper for syringes, needles and certain ● other medical equipment. - Part 1: General requirements
. ISO 594-2 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings

II. Biocompatibility

There were no changes to the material that impacted the biocompatibility of the device. A signed statement of conformance was included in place of testing as the testing from the predicate device was referenced.

. USP <788> Particulate Matter in Injections

III. Sterility

ISO 11135:2014 Sterilization of health-care products Ethylene oxide -. Requirements for the development, validation and routine control of a sterilization process for medical devices

I. Conclusion:

In summary, based on the indication for use, technological characteristics and performance testing, the differences between the MedSource CathMED IV Catheter and the predicate did not raise concern for safety and effectiveness. Therefore, we conclude 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).