MEDSOURCE IV SAFETY CATHETER

K131555 · Medsource International, LLC · FOZ · Jan 31, 2014 · General Hospital

Device Facts

• Record ID: K131555
• Device Name: MEDSOURCE IV SAFETY CATHETER
• Applicant: Medsource International, LLC
• Product Code: FOZ · General Hospital
• Decision Date: Jan 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended 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.

Device Story

MedSource IV Safety Catheter is a single-use, sterile intravascular device for fluid delivery or drainage. It features a sharp needle attached to a hub, housed within a protective chamber. During insertion, the needle is locked; post-insertion, a user-activated lever or switch triggers a spring-loaded retraction mechanism, withdrawing the needle into the enclosed chamber to prevent accidental needle-stick injuries and exposure to patient body fluids. Used in clinical settings by healthcare professionals. The device is available in six gauges (14G-24G). By securing the contaminated needle immediately after use, it reduces the risk of bloodborne pathogen exposure for healthcare personnel.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included chemical analysis (volatile residue, heavy metals, buffering capacity), sterility (ETO), and physical testing (integrity per ISO 10555-1/5, flow-rate, and tensile strength). Results for the subject device were comparable to the predicate device.

Technological Characteristics

Intravascular catheter with spring-loaded needle retraction mechanism. Materials of construction are similar to predicate. Dimensions vary by gauge (14G-24G). Sterilization via ETO. Complies with ISO 10555-1, ISO 10555-5, ISO 10993-10, and ASTM standards for packaging and tensile testing.

Indications for Use

Indicated for blood sampling or intravenous fluid administration in any patient population, contingent upon vascular anatomy, solution appropriateness, and therapy duration.

Regulatory Classification

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.

Predicate Devices

• Becton Dickinson Angiocath Autogaurd (K984059)

Submission Summary (Full Text)

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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: [phone]

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:

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.

#### Description of the Device:

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

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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 Angiocath<br>Autogaud (K984059) | Substantially equivalent |
| Technological<br>Characteristics<br>(Materials of<br>Construction,<br>Dimensions,<br>Performance in) | Becton Dickinson Angiocath<br>Autogaud (K984059) | Materials of construction-same<br>or similar<br>Performance-minor variations<br>Dimensions-minor variations |
| Instructions for Use | Becton Dickinson Angiocath<br>Autogaud (K984059) | Very similar |

Summary of Performance Testing Characteristics:

| | Submission Device ↓ | Predicate Device ↓ |
|---------------------|------------------------------|---------------------------------------------------|
| Comparison Point | MedSource IV Safety Catheter | Becton Dickinson Angiocath<br>Autogaurd (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 and<br>ISO10555-5 | Complies to ISO 10555-1 and<br>ISO10555-5 |
| | | |
| Flow-rate | 14G: 300 ml/min<br>16G: 220 ml/min<br>18G: 105 ml/min<br>20G: 65ml/min<br>22G: 35ml/min<br>24G: 20ml/min | 14G: 300 ml/min<br>16G: 220 ml/min<br>18G: 105 ml/min<br>20G: 65ml/min<br>22G: 35ml/min<br>24G: 20ml/min |
| | | |
| | | |
| | | |
| | | |
| | | |
| Tensile | 18G: 10N<br>20G: 5N<br>22G: 5N<br>24G: 3N | 18G: 10N<br>20G: 5N<br>22G: 5N<br>24G: 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
- 2. ISO 11607-1/2 Packaging for terminally sterilized medical devices
- 3. 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
- 4. DIN 58953-6 "Sterilization paper for bags and tubing pickings ".Testing for germ proof ness in moisture with passage of air
- 5. ASTM F 2054 Standard test method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization within Restraining Plates.
- 6. ASTM F 1980-02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
- 7. ASTM D638 Plastic Tensile Testing
- 8. 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 [phone] or [phone] 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 [phone] or [phone] 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