The MedSource IV Administration Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.

Device Description

The MedSource IV Administration Set is a sterile, single use intravascular administration set used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device includes: 1. Guard for Closure 2. Closure Piercing Device (spike)- Vented with Drip flow rate (either 10, 15, or 60 drops/mL 3. Housing for air-vent with filter 4. Drip Chamber 5. Fluid Filter 6. Tubing 7. Flow Regulator 8. Injection Site (Y-site, Needleless) 9. Male Luer Lock Fitting 10. Protective Cap for Male Fitting

AI/ML Overview

The MedSource IV Administration Set is a medical device designed to administer parenteral fluids. The submission focuses on demonstrating substantial equivalence to a predicate device, the Angletouch IV Administration Set (K012189), through various performance tests.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (MedSource IV Administration Set)	Predicate Device Performance (Angletouch IV Administration Set (K012189))	Result of Comparison
Intended Use	Administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.	Designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.	To Administer parenteral fluids/medication into the patient's intravascular system	Substantially equivalent
Technological Characteristics	Conforms to ISO 8536-4	Conforms to ISO 8536-4	Conforms to ISO 8536-4	Substantially equivalent
Materials of Construction	Materials compatible with intended use (PP, ABS, HDPE, PVC, PP, Latex for predicate)	Poly-Propylene, ABS, PVC, HDPE+Nylon, Silicon, HDPE (all material of not made of natural latex)	PP, ABS, HDPE, PVC, PP, Latex	Substantially equivalent
Performance (Drip Rate)	Drip rate for parenteral fluid administration	Used to administer parenteral fluids at either 10 drops/ml, 15 drops/ml or 60 drops/ml	Use to administer parenteral fluids at 20 drops per ml	Substantially equivalent
Description of Device	Single Use Sterile Infusion Set for Medical Use	Product is a single use sterile infusion set for medical use	The product is a Single Use Sterile Infusion Set for Medical Use	Substantially equivalent
Instructions for Use	Standard procedure for preparing and using an IV administration set.	Prepare IV container, Remove set from pouch and close roller clamp, Remove spike protector from spike, Insert spike into container, Hang container, fill drip chamber by squeezing until approximately half full, remove protector from adaptor, open roller clamp, prime set and purge air from tubing, close roller clamp until roller meet bottom of frame, attached adapter to venipuncture device, adjust fluid flow with roller clamp, check maintenance of proper flow rate at regular intervals.	Disinfect inlet of solution container, remove set from pouch and close the air vent and roller clamp respectively. Remove spike protector from spike, insert spike into solution container, hang container, squeeze drip chamber to fill approximately half full, remove protector from Luer lock adaptor, Open the air vent and roller clamp and solution to expel air from set, close roller clamp and attach set to access device, adjust flow wit roller clamp, check maintenance for proper flow rate a regular intervals.	Substantially equivalent
Chemical Tests		MedSource IV Administration Set	Angletouch IV Administration Set (K012189)
Clarity	Meets stated specification for material (Clear)	Meets stated specification for material	Clear	Pass
Color	Meets stated specification for each material	Meets stated speciation for each material	Meets stated speciation for each material	Pass
Odor	Odorless	Odorless	Odorless	Pass
pH	4.5-7.5	4.5-7.5	4.5-7.5	Pass
Acidity/Alkalinity	NMT 1 ml of 0.01M NaOH / HCl Solution	NMT 1 ml of 0.01M NaOH / HCl Solution	NMT 1 ml of 0.01M NaOH / HCl Solution	Pass
Heavy Metals	NMT 1	NMT 1	NMT 1	Pass
Oxidizable Matter	NMT 2ml	NMT 2ml	HMT 2mL	Pass
No Volatile Matter	NMT 5	NMT 5	NMT 5	Pass
Absorbance	NMT 0.1 in wavelength range 250-320nm	NMT 0.1 in wavelength range 250-320nm	NMT 0.1 in wavelength range 250-320nm	Pass
Biological Tests
Sterility	Sterile ETO	Sterile ETO	Sterile ETO	Pass
Pyrogen	Non pyrogenic	Non pyrogenic	Non pyrogenic	Pass
Toxicity	Non toxic	Non toxic	Non toxic	Pass
Physical Tests
Integrity	No sign of leakage from any join when pressure of 50ka (500mbar) above atmospheric pressure	No sign of leakage from any join when pressure of 50ka (500mbar) above atmospheric pressure	No sign of leakage from any join when pressure of 50ka (500mbar) above atmospheric pressure	Pass
Flow-rate	Deliver not less than 1000 ml of a 0.9% NaCl solution in 10 minutes under static head of one meter.	The complete set should deliver not less than 1000 ml of a 0.9% NaCl solution in 10 minutes under static head of one meter.	Not less than 100ml/min	Pass
Tensile	15N for 15 seconds	15N for 15 seconds	15N	Pass

Study Proving Acceptance Criteria:

The study proving the MedSource IV Administration Set meets the acceptance criteria is a substantial equivalence comparison study against a legally marketed predicate device, the Angletouch IV Administration Set (K012189). This type of study is common for Class II medical devices seeking 510(k) clearance, where the primary goal is to demonstrate that the new device is as safe and effective as a previously cleared device.

Additional Information Required by the Prompt (not explicitly detailed in the provided text):

Since this is a submission for a physical medical device (IV administration set) and not an AI/software device, many of the requested points related to AI/software evaluation (e.g., ground truth, experts, MRMC studies) are not applicable. The information provided focuses on the physical and chemical properties and general performance of the device.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document does not explicitly state the numerical sample size for each specific test (e.g., how many IV sets were tested for flow rate, tensile strength, etc.). It describes the criteria and results of the tests.
Data Provenance: The data provenance is from bench testing conducted on the MedSource IV Administration Set itself and comparative analysis against the specifications and performance of the predicate device (Angletouch IV Administration Set, K012189). This is a prospective evaluation of the new device's performance based on established standards and predicate device data. The country of origin for the testing is not specified, but the submitter is Medsource International, LLC, located in Mound, MN, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable: This request is typically relevant for studies involving subjective human interpretation (e.g., image analysis, diagnosis). For a physical medical device like an IV administration set, the "ground truth" for chemical, biological, and physical properties is established by adherence to recognized consensus standards (e.g., ISO 8536-4, ASTM F1982-07, ISO 954-1/2, etc.) and objective laboratory measurements, rather than expert consensus on subjective interpretations. There's no mention of experts establishing a "ground truth" in this context.

4. Adjudication Method for the Test Set:

Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers or annotators when establishing ground truth for subjective tasks. This is not relevant for the objective physical and chemical testing performed on an IV administration set. The tests performed yield objective, measurable results that either meet or do not meet the predefined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not Done: An MRMC comparative effectiveness study is used to evaluate the performance of human readers with and without AI assistance for interpretative tasks. This is not applicable to the evaluation of a physical IV administration set.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

Not Applicable: This also refers to AI/software performance. The device is a physical IV administration set, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the performance evaluation of the MedSource IV Administration Set is based on:
- Defined Standards and Specifications: Adherence to recognized international consensus standards (e.g., ISO 8536-4, ASTM F1982-07, ISO 954-1/2, EN 980, ISO 11138, BS EM 556-1, ISO 11135).
- Predicate Device Performance: Comparison against the known performance characteristics and materials of the legally marketed predicate device (Angletouch IV Administration Set, K012189).
- Objective Laboratory Measurements: Chemical, biological, and physical tests yielding quantifiable results that are compared against predefined acceptance thresholds derived from these standards and predicate device data.

8. Sample Size for the Training Set:

Not Applicable: This concept of a "training set" is relevant for machine learning algorithms. For a physical device, there isn't a "training set" in the common AI sense. The design and manufacturing process are refined through engineering, testing, and adherence to quality systems and standards, not through "training data."

9. How the Ground Truth for the Training Set Was Established:

Not Applicable: As there is no "training set" in the AI sense, this question is not relevant to the evaluation of this physical medical device.

Summary

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K120424

510(K) Summary

Section 5

Traditional 510(k) Summary Report

Submitter: Medsource International, LLC 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: April 19, 2012

General Information:

Common or Usual Name: Set, I.v. Fluid Transfer �
Proprietary Name: MedSource IV Administration Set
Product Code: LH!
Panel: General Hospital
Classification: Class II
Regulatory Reference: 21 CFR §880.5440
Single Use: Yes
Sterile: Yes
Packaging Materials: pouch made of High molecular high-density polyethylene

Indication for Use: The MedSource IV Administration Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.

Description of the Device Design:

1. Guard for Closure
1. Closure Piercing Device (spike)- Vented with Drip flow rate (either 10, 15, or 60 drops/mL
1. Housing for air-vent with filter
1. Drip Chamber
1. Fluid Filter
1. Tubing
1. Flow Regulator
1. Injection Site (Y-site,

Image /page/0/Figure/28 description: This image shows a diagram of an intravenous (IV) infusion set. The diagram labels the non-vented spike, indicating that 10 drops equal one milliliter. The diagram also labels the roller clamp, split septum injection site, luer lock fitting, and rotating male luer lock.

Tube Length: 63"

FDA 510k Submission: MedSource IV Administration Set

JUL 1 1 2012

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· Needleless) ·

Male Luer Lock Fitting

1. Protective Cap for Male Fitting

Patient Contact

The MedSource IV Administration Set does not come into direct contact with a patient.

Substantially Equivalence Summary:

The MedSource IV Administration Set is substantially equivalent to the Angletouch IV Administration Set (K012189).

Comparison Point	Predicate Device	Subject Device
	Angletouch IVAdministration Set(K012189).	MedSource IVAdministration Set	Result ofComparison
Intended Use	To Administer parenteralfluids/ medication intothe patient'sintravascular system	Designed toadminister parenteralfluids from acontainer to avascular systemthrough a needle orcatheter inserted intoa vein.	Substantiallyequivalent
TechnologicalCharacteristics(Materials ofConstruction,Dimensions,Performance In)	Conforms to ISO 8536-4	Conforms to ISO8536-4	TechnologicalCharacteristics-Substantiallyequivalent
	PP, ABS, HDPE, PVC, PP,Latex,	Poly-Propylene, ABS,PVC, HDPE+Nylon,Silicon, HDPE (allmaterial of not madeof natural latex)	Materials ofconstruction-substantiallyequivalent
	Use to administerparenteral fluids at 20drops per ml	Used it administerparenteral fluids ateither 10 drops/ml, 15drops/ml or 60drops/ml	Performance-substantiallyequivalent
	The product is a SingleUse Sterile Infusion Set forMedical Use	Product is a single usesterile infusion set formedical use	Description ofdevice-substantiallyequivalent
Instructions for Use	Disinfect inlet of solutioncontainer, remove set from	Prepare IV container,Remove set from	Substantiallyequivalent

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	pouch and close the airvent and roller clamprespectively. Removespike protector fromspike, insert spike intosolution container, hangcontainer, squeeze dripchamber to fillapproximately half full,remove protector fromLuer lock adaptor, Openthe air vent and rollerclamp and solution toexpel air from set, closeroller clamp and attachset to access device,adjust flow wit rollerclamp, checkmaintenance for properflow rate a regularintervals.	pouch and closeroller clamp, Removespike protector fromspike, Insert spike intocontainer, Hangcontainer, fill dripchamber bysqueezing untilapproximately halffull, remove protectorfrom adaptor, openroller clamp, primeset and purge airfrom tubing, closeroller clamp until rollermeet bottom offrame, attachedadapter tovenipuncture device,adjust fluid flow withroller clamp, checkmaintenance ofproper flow rate atregular intervals.
--	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--

Conclusion: From the comparison above, it is observed that the MedSource IV Administration Set is found to be substantially equivalent to the Angletouch IV Administration Set (K012189).

Discussion of the Device Characteristics:

The MedSource IV Administration Set is a medical device used for introducing parenteral fluids into the human body. It is a device by which parenteral fluids are entered directly into the vascular system, thereby yielding immediate results for the patients. Since fluids are parenterally entered into body by vein puncture; utmost safety has to be ensured. The sterile IV set is made up different components made up from ABS, PVC, PP, LDPE, HDPE etc. It also consists of an injection site that is not made with natural rubber latex and the needle is made of Stainless steel tube. The product is such that it meets the standard requirement and has no negative effect on the health of the patients or users. Key parts of the product including assembly and packaging are manufactured in class10,000 clean rooms following recognized consensus standards as listed below:

Standard	Title
ISO 8536-4:2004	Infusion Equipment for Medical Use: Part 4 Infusion set ofsingle use, gravity feed
ASTM F1982-07:2009	Standard Guide for Accelerated Aging of Sterile CarrierSystems for Medical Devices
ISO 954-1:1986	Conical Fitting with a 6%(Luer) taper for syringe needles andcertain other medical equipment: Part 1- GeneralRequirements

FDA 510k Submission: MedSource IV Administration Set

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ISO 954-2: 1998	Conical Fitting with a 6%(Luer) taper for syringe needles andcertain other medical equipment: Part 2 Lock Fittings
EN 980: 2008	Symbols for use in the labeling of Medical Devices
ISO 11138:2006	Sterilization of Health Care Products-Biological Indicators:Part 1 General Requirements
BS EM 556-1:2001	Sterilization of Medical Devices: Part 1 requirements forterminally sterilized medical device to be designated"sterile"
ISO 11135: 2007	Sterilization of Health Care Product- Ethylene Oxide: Part 1Requirements for development, validation, and routinecontrol of sterilization

Identification of the Risk Analysis Method:

Risk analysis was performed per internationally recognized consensus standard, ISO . 14971:2007, below is the summary of the results and actions taken to mitigate those risks.

Identified Risk	Recommended Mitigation Measures
Device Malfunction	Complete Bench Testing
Adverse Tissue Reaction	Biocompatibility Testing
Infection	Sterility Testing, Microbial Ingress .Testing, Clinical Use Testing
Improper Use	Labeling

Summary of Performance Testing Characteristics:

	Submission Device ↓	Predicate Device ↓
Comparison Point ↓	MedSource IV AdministrationSet	Angletouch IV Administration Set(K012189)

1 . Book . Chemical Chemical Test

Clarity	Meets stated specification formaterial	Clear
Color	Meets stated speciation for eachmaterial	Meets stated speciation for eachmaterial
Odor	Odorless	Odorless
pH	4.5-7.5	4.5-7.5
Acidity/ Alkalinity	NMT 1 ml of 0.01MNaOH / HClSolution	NMT 1 ml of 0.01MNaOH / HClSolution
Heavy Metals	NMT 1	NMT 1
Oxidizable Matter	NMT 2ml	HMT 2mL
No Volatile Matter	NMT 5	NMT 5
Absorbance	NMT 01 in wavelength range250-320nm	NMT 01 in wavelength range 250-

FDA 510k Submission: MedSource IV Administration Set

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		320nm
	Biological Tests
Sterility	Sterile ETO	Sterile ETO
Pyrogen	Non pryogenic	Non pryogenic
Toxicity .	Non toxic	Non toxic
	Physical Tests
Integrity	no sign of leakage from any joinwhen pressure of 50ka(500mbar) above atmosphericpressure	no sign of leakage from any joinwhen pressure of 50ka (500mbar)above atmospheric pressure
Flow-rate	the complete set should delivernot less then 1000 ml of a0.9% NaCl solution in 10minutes under static head of onemeter.	Not less than 100ml/min
Tensile	15N for 15 seconds	15N

Conclusion: The results in the above table demonstrate that the MedSource IV Administration Set performance meets or exceeds the performance of the predicate device.

Biocompatibility:

The MedSource IV Administration Set is comprised of identical materials that are processed by identical manufacturing methods as used in a predicate, Angletouch IV Administration Set (K012189), with the same type and duration of patient contact, therefore per Guidance Document, "Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" biocompatibility testing is not required.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

MedSource International, LLC. Ms. Jennifer Ness Quality and Regulatory Affairs Manager 5346 Shoreline Drive Mound, Minnesota 55364

JUL 11 2012

Re: K120424

Trade/Device Name: MedSource IV Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: June 25, 2012 Received: June 27, 2012

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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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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,

For

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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): K120424

Device Name: MedSource I.V. Set

Indications For Use: The MedSource IV Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

unter Use
(Subpart C)

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

oncurrence of CDRH, Office of Device Evaluation (ODE)

7/10/2012
Division Sign-Off)

്‌।vision of Anesthesiology, General Hospital vection Control, Dental Devices

K120424 10(k) Number:

Page 1 of

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.