20G x 5/8 Pro-Lock CT Safety Infusion Set

K171333 · Medcomp (Dba Medical Components, Inc.) · PTI · Jul 18, 2017 · General Hospital

Device Facts

• Record ID: K171333
• Device Name: 20G x 5/8 Pro-Lock CT Safety Infusion Set
• Applicant: Medcomp (Dba Medical Components, Inc.)
• Product Code: PTI · General Hospital
• Decision Date: Jul 18, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medcomp® Pro-Lock™ CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sample through implanted vascular access ports. The Medcomp® Pro-Lock™ CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles.

Device Story

The Pro-Lock CT Safety Infusion Set is a non-coring Huber style needle assembly used to access implanted vascular access ports. It consists of a stainless steel needle cannula, extension tubing, a female Luer connector, and a non-removable pinch clamp. The device includes a safety mechanism designed to prevent accidental needle sticks by automatically activating during needle removal. It is used by clinicians in clinical settings to deliver fluids, drugs, or contrast media (via power injection) and to perform blood sampling. The device facilitates secure connection to standard IV/drug infusion lines. By providing a safe, reliable access point to the central venous system, it enables therapeutic delivery and diagnostic sampling while protecting healthcare workers from sharps injuries.

Clinical Evidence

Bench testing only. No clinical data. Testing included priming volume, gravity flow, needle insertion/extraction force, air/liquid leakage, Luer lock fittings, occlusion, tensile strength, power injection simulation, port septum coring, static load pull, corrosion resistance, shelf life, shipping, sharps injury prevention, and MR compatibility (ASTM F2052, F2119, F2182, F2213, F2503). Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Cannula: Stainless steel; Female Luer: PVC; Extension: Pellethane; Clamp/Base: Polypropylene; Sleeve: PVC. Sterilization: Ethylene Oxide (EO). Design: Huber style needle with safety shield and living hinge. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring administration of fluids, drugs, or blood sampling via implanted vascular access ports, and for power injection of contrast media in ports specifically indicated for power injection.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Pro-Lock CT Safety Infusion Set (K162271)

Submission Summary (Full Text)

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

July 18, 2017

Medcomp (dba Medical Components, Inc.) Courtney Nix Regulatory Affairs Manager. North America and EU 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K171333

Trade/Device Name: Pro-Lock CT Safety Infusion Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: Julv 7, 2017 Received: July 10, 2017

Dear Courtney Nix:

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Tara A. Ryan -S

for

Lori Wiggins 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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| Form Approved: OMB No. 0910-0120 | |
|-----------------------------------|--|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

**Indications for Use**

| 510(k) Number (if known) | K171333 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Pro-Lock™ CT Safety Infusion Set |
| Indications for Use (Describe) | The Medcomp® Pro-Lock™ CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sample through implanted vascular access ports. The Medcomp® Pro-Lock™ CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles. |

| Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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Image /page/3/Picture/0 description: The image shows the logo for medCOMP. The logo features a stylized red and white design above the text "medCOMP". The design consists of geometric shapes, including a circle and angled lines, creating a modern and abstract look.

1499 Delp Drive Harleysville, PA 19438

Tel: [phone]

Fax. [phone]

www.medcompnet.com

| Section 6 | 510(k) SUMMARY | Traditional 510K |
|-----------|-----------------------------------------|--------------------------------------------------|
| 1. | Submitter Information: | |
| | Submitter: | Medcomp® |
| | | 1499 Delp Drive |
| | | Harleysville, PA 19438 |
| | | Tel: [phone], x 2285 |
| | | Fax: [phone] |
| | Registration Number: | 2518902 |
| | Contact: | Courtney Nix |
| | | [e-mail] |
| | | Regulatory Affairs Manager: North America and EU |
| | Date Prepared: | 05/05/2017 |
| 2. | Proposed or Subject Device Information: | |
| | Trade Name: | Pro-Lock ^TM CT Safety Infusion Set |
| | Device: | Non-Coring (Huber) Needle |
| | Product Code: | PTI |
| | Regulation Description: | Single Lumen Hypodermic Needle |
| | C.F.R. Section: | 21 CFR 880.5570 |
| | Class: | II |
| | Review Panel: | General Hospital |
| 3. | Predicate Device Information: | |
| | 510(k) Number: | K162271 |
| | Trade Name: | Pro-Lock ^TM CT Safety Infusion Set |
| | Device: | Non-Coring (Huber) Needle |
| | Product Code: | PTI |
| | C.F.R. Section: | 21 CFR 880.5570 |

Medcomp®: 20G x 5/8" Pro-Lock™ CT Safety Infusion Set Section 6: 510(k) Site Summary

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Image /page/4/Picture/0 description: The image shows the MedComp logo. The logo is red and white. The logo has a stylized letter "M" with a white circle in the middle. The word "medCOMP" is written in red below the stylized letter "M".

A.

5.

#### 1499 Delp Drive

Harleysville, PA 19438

Tel: [phone]

Fax. [phone]

www.medcompnet.com

### Device Description:

The 20G x 5/8" (15mm) Pro-Lock™ CT Safety Infusion Set is composed of a Huber style needle for port septum access having a safety feature designed to prevent accidental needle sticks and automatically activate during needle removal. The needle is connected to a conventional style extension set. The proximal end of the extensions tubing attaches to a female Luer connector with removable cap creating a fluid path to the port. A non-removable pinch clamp is located between the female Luer and needle cannula which is designed to restrict fluid flow through the extension tubing when engaged.

The needle cannula is constructed with a Huber style needle. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.

### Indications for Use:

The Medcomp® Pro-Lock™ CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implanted vascular access ports. The Medcomp® Pro-Lock™ CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous svstem with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/sec for 20 gauge non-coring Huber style needles.

#### Comparison to Predicate Devices: 6.

The 20G x 5/8" (15mm) Pro-Lock™ CT Safety Infusion Set is substantially equivalent to the predicate device, 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set (K162271), in terms of indications for use, intended use, materials, biocompatibility, basic design, performance, labeling, patient user inference and manufacturing process.

The difference between the predicate device, 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set (K162271), and the 20G x 5/8" (15 mm) Pro-Lock™ CT Safety Infusion Set is the change in needle length from %" to 5/8" and hinge lenath from 1.164" to 1.114".

| Device | Proposed Device:<br>20G x 5/8" (15mm) Pro-<br>LockTM CT Safety Infusion Set | Predicate Device:<br>20G x 3/4" (19mm) Pro-LockTM<br>CT Safety Infusion Set<br>(K162271) |
|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Anti-coring Huber style needle<br>for port septum access having<br>a safety feature which that will<br>prevent accidental needle<br>sticks. The needle is<br>connected to a conventional | Anti-coring Huber style needle<br>for port septum access having<br>a safety feature which that will<br>prevent accidental needle<br>sticks. The needle is connected<br>to a conventional style |
| | | |
| | style extension set for<br>attachment to standard<br>IV/Drug infusion line sets. | extension set for attachment to<br>standard IV/Drug infusion line<br>sets. |
| Dimensions<br>or Lengths | 5/8" | 3/4" |
| Indications<br>for Use | The Medcomp® Pro-Lock ™<br>CT Safety Infusion Set is<br>intended for use in the<br>administration of fluids and<br>drugs as well as blood<br>sampling through implanted<br>vascular access ports. The<br>Medcomp® Pro-Lock™ CT<br>Safety Infusion Set is also<br>indicated for power injection of<br>contrast media into the central<br>venous system with implanted<br>vascular access ports<br>indicated for power injection.<br>The maximum recommended<br>infusion rate at 11.8 cPs is 5<br>ml/sec for 20 gauge non-<br>coring Huber style needles. | The Medcomp® Pro-Lock ™ CT<br>Safety Infusion Set is intended<br>for use in the administration of<br>fluids and drugs as well as<br>blood sampling through<br>implanted vascular access<br>ports. The Medcomp® Pro-<br>Lock™ CT Safety Infusion Set<br>is also indicated for power<br>injection of contrast media into<br>the central venous system with<br>implanted vascular access<br>ports indicated for power<br>injection. The maximum<br>recommended infusion rate at<br>11.8 cPs is 5 ml/sec for 20<br>gauge non-coring Huber style<br>needles. |
| Intended Use | The Pro-Lock™ CT Safety<br>Infusion Set is intended for<br>use in the administration of<br>fluids and drugs, as well as<br>blood sampling through<br>surgically implanted vascular<br>ports. | The Pro-Lock™ CT Safety<br>Infusion Set is intended for use<br>in the administration of fluids<br>and drugs, as well as blood<br>sampling through surgically<br>implanted vascular ports. |
| Gauge Sizes | 20 GA | 20 GA |
| Sterilization<br>Method | EO | EO |
| Materials | Cannula: Stainless Steel<br>Female Luer: PVC<br>Extension: Pellethane<br>Clamp: Polypropylene<br>Base: Polypropylene<br>Sleeve: PVC | Cannula: Stainless Steel<br>Female Luer: PVC<br>Extension: Pellethane<br>Clamp: Polypropylene<br>Base: Polypropylene<br>Sleeve: PVC |
| Performance<br>Testing | Maximum Infusion Rate:<br>11.8 cPs is 5 ml/sec for 20<br>gauge<br><br>Priming Volume: 0.20cc<br><br>Maximum Flow Rate: | Maximum Infusion Rate:<br>11.8 cPs is 5 ml/sec for 20<br>gauge<br><br>Priming Volume: 0.20cc<br><br>Maximum Flow Rate: |
| Test Performed | Test Method | |
| Priming Volume | Per Internal Test Method | |
| Gravity Flow | ISO 10555-1: 2013 - Incorporating corrigendum April<br>2014 - Intravascular catheters - Sterile and single-<br>use catheters Part 1: General Requirements | |
| Needle<br>Insertion/Extractio<br>n Force | ISO 10555-6: 2015 - Intravascular catheters - Sterile<br>and single-use catheters - Part 6: Subcutaneous<br>implanted | |
| Air Leakage | ISO 8536-8: 2004 - Infusion equipment for medical<br>use - Part 8: Infusion equipment for use with<br>pressure infusion apparatus | |
| Test Performed | Test Method | |
| Liquid Leakage | ISO 10555-1: 2013 - Incorporating corrigendum April<br>2014 - Intravascular catheters - Sterile and single-<br>use catheters Part 1: General Requirements, Annex<br>C | |
| Luer Lock Fittings | ISO 594-2: 1998 - Conical fittings with 6 % (Luer)<br>taper for syringes, needles and certain other medical<br>equipment | |
| Occlusion with<br>Clamp | Per Internal Test Method | |
| Extension Tensile<br>and % Elongation | ISO 10555-1: 2013 - Incorporating corrigendum April<br>2014 - Intravascular catheters - Sterile and single-<br>use catheters Part 1: General Requirements | |
| Power Injection<br>Simulation | ISO 10555-1: 2013 - Incorporating corrigendum April<br>2014 - Intravascular catheters - Sterile and single-<br>use catheters Part 1: General Requirements | |
| Port<br>Septum/Needle<br>Evaluation for<br>Coring | Per Internal Test Method | |
| Break Pull Test/<br>Static Load Pull<br>Test | ISO 10555-1: 2013 - Incorporating corrigendum April<br>2014 - Intravascular catheters - Sterile and single-<br>use catheters Part 1: General Requirements | |
| Needle to<br>Extension Joint | ISO 10555-1: 2013 - Incorporating corrigendum April<br>2014 - Intravascular catheters - Sterile and single- | |
| Corrosion<br>Resistance | ISO 11070: 2014 - Sterile single-use intravascular<br>introducers, dilators and guidewires | |
| Shelf Life (3<br>years) | ISO 11607-1: 2009+A1:2014- Packaging for<br>terminally sterilized medical devices - Part 1:<br>Requirements for materials sterile barrier systems<br>and packaging<br>ASTM F1980-16, Standard guide for accelerated<br>aging of sterile barrier systems for medical<br>ISO 10555-1: 2013 - Incorporating corrigendum April<br>2014 - Intravascular catheters - Sterile and single-<br>use catheters Part 1: General Requirements<br>ASTM F-1929-15-, Standard Test Method for<br>Detecting Seal Leaks in Porous Medical Packaging<br>by Dye Penetration<br>ASTM F-1140- Standard Test Methods for Internal<br>Pressurization Failure Resistance of Unrestrained<br>Packages | |
| Shipping Test | ISO 11607-1: 2009+A1:2014- Packaging for<br>terminally sterilized medical devices - Part 1:<br>Requirements for materials sterile barrier systems<br>and packaging<br>ISTA-2A-2011 - Performance Tests for Packaged-<br>Products, Packaged-Products 150lb (68 kg) or Less<br>ASTM F-1929-15-, Standard Test Method for<br>Detecting Seal Leaks in Porous Medical Packaging<br>by Dye Penetration<br>ASTM F-1140- Standard Test Methods for Internal<br>Pressurization Failure Resistance of Unrestrained<br>Packages | |
| Simulated Use<br>Study: Sharps<br>Injury Prevention | FDA's Guidance: Medical Devices with Sharps<br>Injury Prevention Features | |
| Living Hinge<br>Fatigue | Per Internal Test Method | |
| Force at Break | Per Internal Test Method | |
| Evaluation of<br>Magnetic Field<br>Interactions,<br>Heating, and<br>Artifacts | ASTM F2052-15 - Standard Test Method for<br>Measurement of Magnetically Induced Displacement<br>Force on Medical Devices in the Magnetic<br>Resonance Environment<br>ASTM F2119-07 - Standard Test Method for<br>Evaluation of MR Image Artifacts from Passive<br>Implants<br>F2182-11a - Standard Test Method for Measurement<br>of Radio Frequency Induced Heating On or Near<br>Passive Implants During Magnetic Resonance<br>Imaging | |

#### Table 6.1: 510(K) Summary: Design Comparison Matrix

Medcomp®: 20G x 5/8" Pro-Lock™ CT Safety Infusion Set Section 6: 510(k) Site Summary

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Image /page/5/Picture/0 description: The image shows a logo for medCOMP. The logo features a red geometric design with a white circle on the left side. The text "medCOMP" is written in a stylized font below the geometric design, with "med" in red and "COMP" in gray.

1499 Delp Drive Harleysville, PA 19438 Tel: [phone] Fax. [phone] www.medcompnet.com

Medcomp®: 20G x 5/8" Pro-Lock™ CT Safety Infusion Set Section 6: 510(k) Site Summary

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Image /page/6/Picture/0 description: The image shows the MedComp logo. The logo consists of a red and white geometric shape above the word "medCOMP" in red and gray. The geometric shape is made up of lines and curves, and it has a white circle in the lower left corner.

7.

1499 Delp Drive Harleysville, PA 19438

Tel: [phone]

Fax. [phone]

www.medcompnet.com

# Bench / Performance Data / Non-Clinical Testing:

The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, 20G x 5/8" (15mm) Pro-Lock™ CT Safety Infusion Set, is equivalent to the predicate device, 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set (K162271).

Table 6.2 Bench Testing and Reference Standards:

Medcomp®: 20G x 5/8" Pro-Lock™ CT Safety Infusion Set Section 6: 510(k) Site Summary

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Image /page/7/Picture/0 description: The image shows a logo for medCOMP. The logo is a red and white design with a circle on the left side. The text "med" is in red and "COMP" is in gray.

1499 Delp Drive

Tel: [phone] Fax. [phone] www.medcompnet.com

Harleysville, PA 19438

Pull

use catheters Part 1: General Requirements

Medcomp®: 20G x 5/8" Pro-Lock™ CT Safety Infusion Set Section 6: 510(k) Site Summary

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Image /page/8/Picture/0 description: The image shows a logo for medCOMP. The logo features a stylized geometric shape in red and white, resembling an abstract building or structure. Below the shape, the word "med" is written in red, followed by "COMP" in gray.

1499 Delp Drive

Harleysville, PA 19438

Tel: [phone]

Fax. [phone]

www.medcompnet.com

F2213-06 - Standard test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment ASTM F 2503-13 -- Standard practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

## Biocompatibility:

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Biocompatibility was performed on the final, finished Pro-Lock™ CT Safety Infusion Set per ISO 10993-1 for an externally communicating device, with indirect blood path exposure for a prolonged duration with the body, greater than 24 hours and less than 30 days. The biological endpoints include:

- Sensitization/Irritation: ISO 10993-10: 2010 Biological Evaluation of ে Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
- · Acute Systemic Toxicity: ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11: Tess for Systemic Toxicity
- Cytotoxicity: ISO 10993-5: 2009 Biological Evaluation of Medical ে থ Devices - Part 10: Tests for in vitro Cytotoxicity
- Pyrogenicity: ISO 10993-11: 2006 Biological Evaluation of Medical o Devices - Part 11: Test for Systemic Toxicity
- Hemocompatibility; ISO 10993-4: 2002 Amended 2006 Biological . Evaluation of Medical Devices - Part 4: Selection for tests for interactions with blood
- Material Characterization: ISO 10993-18: 2005 Biological Evaluation of . Medical Devices - Part 18: Chemical Characterization of Materials

#### Summary of Substantial Equivalence: ல்

In conclusion, the proposed device, 20G x 5/8" (15mm) Pro-Lock™ CT Safety Infusion Set, is considered substantially equivalent to the predicate device, 20G x 34" (19mm) Pro-Lock™ CT Safety Infusion Set (K162271) as demonstrated through non-clinical testing performed.

Medcomp®: 20G x 5/8" Pro-Lock™ CT Safety Infusion Set Section 6: 510(k) Site Summary