MEDSOURCE IV ADMINSTRATION SET

K120424 · Medsource International, LLC · LHI · Jul 11, 2012 · General Hospital

Device Facts

• Record ID: K120424
• Device Name: MEDSOURCE IV ADMINSTRATION SET
• Applicant: Medsource International, LLC
• Product Code: LHI · General Hospital
• Decision Date: Jul 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The MedSource IV Administration Set is a sterile, single-use gravity-fed infusion device. It consists of a vented spike for container access, a drip chamber (available in 10, 15, or 60 drops/mL configurations), fluid filter, PVC/polypropylene tubing, flow regulator (roller clamp), and a Y-site injection port with a male luer lock fitting. The device is operated by healthcare professionals to deliver parenteral fluids to a patient's vascular system. The operator inserts the spike into the fluid container, primes the tubing to remove air, connects the luer lock to the patient's venous access device, and adjusts the flow rate using the roller clamp. The device facilitates controlled fluid delivery, which is essential for patient hydration or medication administration. It does not come into direct contact with the patient.

Clinical Evidence

Bench testing only. Testing included chemical analysis (pH, heavy metals, oxidizable matter), physical integrity (leakage testing at 50kPa), flow rate verification (delivering 1000 mL in 10 minutes under 1-meter static head), and tensile strength (15N for 15 seconds). Sterility and pyrogenicity were confirmed via ETO sterilization validation.

Technological Characteristics

Materials: Polypropylene, ABS, PVC, HDPE, Nylon, Silicon. Conforms to ISO 8536-4 (infusion sets), ISO 954-1/2 (luer fittings), and ASTM F1982-07. Gravity-fed infusion principle. Dimensions: 63" tubing. Sterilization: Ethylene Oxide (ETO) per ISO 11135. No software or electronic components.

Indications for Use

Indicated for the administration of parenteral fluids from a container to a patient's vascular system via a needle or catheter inserted into a vein.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Angletouch IV Administration Set (K012189)

Submission Summary (Full Text)

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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: [phone]

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:

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,

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) ·

9. Male Luer Lock Fitting

- 10. 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 IV<br>Administration Set<br>(K012189). | MedSource IV<br>Administration Set | Result of<br>Comparison |
| Intended Use | To Administer parenteral<br>fluids/ medication into<br>the patient's<br>intravascular system | Designed to<br>administer parenteral<br>fluids from a<br>container to a<br>vascular system<br>through a needle or<br>catheter inserted into<br>a vein. | Substantially<br>equivalent |
| Technological<br>Characteristics<br>(Materials of<br>Construction,<br>Dimensions,<br>Performance In) | Conforms to ISO 8536-4 | Conforms to ISO<br>8536-4 | Technological<br>Characteristics-<br>Substantially<br>equivalent |
| | PP, ABS, HDPE, PVC, PP,<br>Latex, | Poly-Propylene, ABS,<br>PVC, HDPE+Nylon,<br>Silicon, HDPE (all<br>material of not made<br>of natural latex) | Materials of<br>construction-<br>substantially<br>equivalent |
| | Use to administer<br>parenteral fluids at 20<br>drops per ml | Used it administer<br>parenteral fluids at<br>either 10 drops/ml, 15<br>drops/ml or 60<br>drops/ml | Performance-<br>substantially<br>equivalent |
| | The product is a Single<br>Use Sterile Infusion Set for<br>Medical Use | Product is a single use<br>sterile infusion set for<br>medical use | Description of<br>device-<br>substantially<br>equivalent |
| Instructions for Use | Disinfect inlet of solution<br>container, remove set from | Prepare IV container,<br>Remove set from | Substantially<br>equivalent |

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| | pouch and close the air<br>vent and roller clamp<br>respectively. Remove<br>spike protector from<br>spike, insert spike into<br>solution container, hang<br>container, squeeze drip<br>chamber to fill<br>approximately half full,<br>remove protector from<br>Luer lock adaptor, Open<br>the air vent and roller<br>clamp and solution to<br>expel air from set, close<br>roller clamp and attach<br>set to access device,<br>adjust flow wit roller<br>clamp, check<br>maintenance for proper<br>flow rate a regular<br>intervals. | pouch and close<br>roller clamp, Remove<br>spike protector from<br>spike, Insert spike into<br>container, Hang<br>container, fill drip<br>chamber by<br>squeezing until<br>approximately half<br>full, remove protector<br>from adaptor, open<br>roller clamp, prime<br>set and purge air<br>from tubing, close<br>roller clamp until roller<br>meet bottom of<br>frame, attached<br>adapter to<br>venipuncture device,<br>adjust fluid flow with<br>roller clamp, check<br>maintenance of<br>proper flow rate at<br>regular 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 of<br>single use, gravity feed |
| ASTM F1982-07:2009 | Standard Guide for Accelerated Aging of Sterile Carrier<br>Systems for Medical Devices |
| ISO 954-1:1986 | Conical Fitting with a 6%(Luer) taper for syringe needles and<br>certain other medical equipment: Part 1- General<br>Requirements |

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 and<br>certain 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:<br>Part 1 General Requirements |
| BS EM 556-1:2001 | Sterilization of Medical Devices: Part 1 requirements for<br>terminally sterilized medical device to be designated<br>"sterile" |
| ISO 11135: 2007 | Sterilization of Health Care Product- Ethylene Oxide: Part 1<br>Requirements for development, validation, and routine<br>control 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 .<br>Testing, Clinical Use Testing |
| Improper Use | Labeling |

## Summary of Performance Testing Characteristics:

| | Submission Device ↓ | Predicate Device ↓ |
|--------------------|------------------------------------|-----------------------------------------------|
| Comparison Point ↓ | MedSource IV Administration<br>Set | Angletouch IV Administration Set<br>(K012189) |

1 . Book . Chemical Chemical Test

| Clarity | Meets stated specification for<br>material | Clear |
|---------------------|----------------------------------------------|----------------------------------------------|
| Color | Meets stated speciation for each<br>material | Meets stated speciation for each<br>material |
| Odor | Odorless | Odorless |
| pH | 4.5-7.5 | 4.5-7.5 |
| Acidity/ Alkalinity | NMT 1 ml of 0.01MNaOH / HCl<br>Solution | NMT 1 ml of 0.01MNaOH / HCl<br>Solution |
| Heavy Metals | NMT 1 | NMT 1 |
| Oxidizable Matter | NMT 2ml | HMT 2mL |
| No Volatile Matter | NMT 5 | NMT 5 |
| Absorbance | NMT 01 in wavelength range<br>250-320nm | 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 join<br>when pressure of 50ka<br>(500mbar) above atmospheric<br>pressure | no sign of leakage from any join<br>when pressure of 50ka (500mbar)<br>above atmospheric pressure |
| Flow-rate | the complete set should deliver<br>not less then 1000 ml of a<br>0.9% NaCl solution in 10<br>minutes under static head of one<br>meter. | 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 [phone] or [phone] 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)

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K120424 10(k) Number:

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