Medcomp Vessel Dilator

K162389 · Medcomp ( Medical Components) · DRE · Jun 1, 2017 · Cardiovascular

Device Facts

• Record ID: K162389
• Device Name: Medcomp Vessel Dilator
• Applicant: Medcomp ( Medical Components)
• Product Code: DRE · Cardiovascular
• Decision Date: Jun 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Medcomp® Vessel Dilator is intended for use for short term vascular access for percutaneous catheterization.

Device Story

Medcomp Vessel Dilator facilitates percutaneous vascular access; device enlarges vessel opening for subsequent catheter placement. Device consists of polyethylene or polypropylene tubing attached to HDPE hub; available in 4F-24F sizes, 15cm or 20cm lengths, single or dual taper configurations. Compatible with .025", .035", and .038" guidewires. Used by clinicians in clinical settings for short-term vascular access. Device is sterile, single-use, and intended for aseptic technique. Output is physical dilation of vessel entry site, enabling successful catheter insertion. Benefits include simplified, standardized vessel access for venous or arterial procedures.

Clinical Evidence

Bench testing only. Performance testing conducted per ISO 11070:2014 and ISO 10555-1. Biocompatibility testing performed per ISO 10993-1 for limited contact (≤24 hours) external communicating device with indirect blood contact. Sterility validated per ISO 11135 and ISO 10993-7.

Technological Characteristics

Materials: Polyethylene or polypropylene tubing, HDPE hub. Dimensions: 4F-24F, 15cm/20cm lengths. Guidewire compatibility: .025", .035", .038". Sterilization: Ethylene Oxide (EO). Standards: ISO 11070, ISO 10555-1, ISO 10993-1, ISO 11135, ISO 14971.

Indications for Use

Indicated for percutaneous entry into a vessel to enlarge the opening for catheter placement in a vein or artery.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

• Merit® Medical Percutaneous Vessel Dilator (K801113)

Reference Devices

• Cook® Dilator (Preamendment Device, Device Listing Number D012540)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above and below the profiles.

Public Health Service

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

June 1, 2017

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

Re: K162389

Trade/Device Name: Medcomp Vessel Dilator Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: April 20, 2017 Received: April 24, 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 Part 807); labeling (21 CFR Part 801); medical device 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.

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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,

Fernando
Fernando Aguel-S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K162389

Device Name Medcomp Vessel Dilator

Indications for Use (Describe)

The Medcomp Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows a logo for MedComp. The logo consists of a pink geometric shape that resembles a stylized house or building. Below the shape, the word "med" is written in pink, followed by "COMP." in gray.

1499 Delp Drive

Harleysville, PA 19438

Tel: [phone]

Fax. [phone]

www.medcompnet.com

| Section 6 | | 510(k) Summary |
|-----------|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| A. | Submitter Information: | |
| | Submitter: | Medcomp®<br>1499 Delp Drive<br>Harleysville, PA 19438<br>Tel: [phone], x 2285<br>Fax: [phone] |
| | Registration Number: | 2518902 |
| | Contact: | Courtney Nix<br>[e-mail]<br>Regulatory Affairs Manager: North<br>America and EU |
| | Date Prepared: | 08/23/2016 |
| B. | Proposed or Subject Device Information: | |
| | Trade Name: | Medcomp® Vessel Dilator |
| | Common/Usual Name: | Vessel Dilator |
| | Device: | Dilator, Vessel, for Percutaneous<br>Catheterization |
| | Product Code: | DRE |
| | Regulation Description: | Vessel Dilator for percutaneous<br>catheterization |
| | C.F.R. Section: | 21 CFR 870.1310 |
| | Class: | II |
| | Regulation Medical<br>Specialty and Review<br>Panel: | Cardiovascular |
| B. | Predicate Device: | |
| | 510(k) Number: | K801113 |
| | 510(k) Holder: | Merit® Medical |
| | Trade Name: | Percutaneous Vessel Dilator |
| | Common/Usual Name: | Dilator |

Section 6: 510K Summary

Medcomp®: Vessel Dilator

K162389

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Image /page/4/Picture/0 description: The image shows a logo with a geometric design in red, resembling an abstract house or arrow shape. Below the geometric shape, the word "med" is written in red, followed by "COMP" in gray. The logo appears to be for a company named Medcomp.

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

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Medcomp®: Vessel Dilator

| Device: | Dilator, Vessel for Percutaneous<br>Catheterization |
|------------------------------------------------------|-------------------------------------------------------|
| Product Code: | DRE |
| Regulation Description: | Vessel Dilator for percutaneous<br>catheterization |
| C.F.R Section: | 21 CFR 870.1310 |
| Class: | II |
| Regulation Medical<br>Specialty and Review<br>Panel: | Cardiovascular |
| Reference Device Information: | |
| 510(k) Number: | Preamendment Device, Device Listing<br>Number D012540 |
| 510(k) Holder: | Cook® Incorporated |
| Trade Name: | Dilator |
| Common/Usual Name: | Dilator |
| Device: | Dilator, Vessel for Percutaneous<br>Catheterization |
| Product Code: | DRE |
| Regulation Description: | Vessel Dilator for percutaneous<br>catheterization |
| C.F.R Section: | 21 CFR 870.1310 |
| Class: | II |
| Regulation Medical<br>Specialty and Review<br>Panel: | Cardiovascular |

Purpose for Submission:

The purpose of this submission is to obtain 510(k) clearance for a new product line for Medcomp®.

Device Description:

Medcomp®: Vessel Dilator Section 6: 510K Summary

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Medcomp®: Vessel Dilator

Image /page/5/Picture/1 description: The image shows the MedComp logo. The logo features a stylized, geometric shape in pink, resembling a house or an abstract letter. Below the shape, the word "medCOMP" is written in a lowercase, italicized font, with "med" in pink and "COMP" in a darker shade. The logo appears to be clean and modern, with a focus on simplicity and visual appeal.

1499 Delp Drive Harlevsville, PA 19438 Tel: [phone] Fax. [phone] www.medcompnet.com Indications for Use:

The Medcomp® Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.

(polvethylene or polypropylene) attached to an HDPE hub. Vessel dilators are supplied sterile, for use in an aseptic technique and can only be used once.

Medcomp®s Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter into a vein or artery. The Vessel Dilators range in size from 4F to 24F with lengths of either 15cm (6.0 inches) or 20cm (8.0 inches), are either single

or dual taper, and can use guidewire sizes .025", .035", and .038". The Medcomp® Vessel dilators are offered in two different tubing materials

Intended Use:

G.

H.

The Medcomp® Vessel Dilator is intended for use for short term vascular access for percutaneous catheterization.

### 1. Comparison to Predicate and Reference Devices:

The Medcomp® Vessel Dilator is substantially equivalent to the predicate device, Merit® Medical Percutaneous Vessel Dilator (K801113), and the reference device, Cook® Dilator, preamendment, in terms of indications for use, intended use, specifications, anatomical location, biocompatibility, performance, and labeling.

The difference between the predicate device. Merit® Medical Percutaneous Vessel Dilator (K801113), and the reference device, Cook® Dilator (Preamendment), and the Medcomp® Vessel Dilator is the additional product offering made from polyethylene.

Table 5.1: 510(K) Summary: Design Comparison Matrix

| Device | Medcomp®<br>Vessel Dilator<br>(Proposed) | Cook® Dilator<br>Preamendment<br>(Reference) | Merit® Medical<br>Percutaneous<br>Vessel Dilator<br>K801113<br>(Predicate) | Substantially<br>Equivalent<br>Comparison |
|--------|--------------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------|
| Design | French Size<br>Ranges: 4F-24F | French Size<br>Ranges: 3F-24F | French Size<br>Ranges: 4F-6F | Equivalent |
| | Lengths: 15cm,<br>20cm | Lengths: 10cm,<br>15cm, 20cm | Lengths: 20cm | |
| | Guidewire Sizes:<br>.025", .035",<br>.038" | Guidewire Sizes:<br>.018", .025",<br>.035", .038" | Guidewire Sizes:<br>.035", .038" | |

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Medcomp®: Vessel Dilator

1499 Delp Drive

Tel: [phone] Fax. [phone]

Harleysville, PA 19438

www.medcompnet.com

| Indications<br>for Use | The Medcomp<br>vessel dilators<br>are designed for<br>percutaneous<br>entry into a<br>vessel in order<br>to enlarge the<br>opening of the<br>vessel for the<br>placement of a<br>catheter in a<br>vein or artery. | Legally<br>Marketed | The Merit®<br>Medical vessel<br>dilators are<br>designed for<br>percutaneous<br>entry into a<br>vessel utilizing<br>the Seldinger<br>technique in order<br>to enlarge the<br>opening of the<br>vessel for the<br>placement of a<br>catheter in a vein<br>or artery. | Equivalent to<br>Predicate Devic |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Sterilization | EO | EO | Legally Marketed | Equivalent |
| Materials | Polyethylene<br>Tube<br><br>Polypropylene<br>Tube | Legally<br>Marketed | Polypropylene | Equivalent |

#### J. Bench / Performance Data / Non-Clinical Testing:

The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, Medcomp® Vessel Dilator, is equivalent to the reference device, Cook® Dilator, preamendment. The performance testing was performed in accordance with the following standards:

- ISO 11070:2014 Sterile single-use intravascular introducers. ● dilators and quidewires
- 。 ISO10555-1 Second edition 2013-07-01, sterile, single-use intravascular catheters - part 1: general requirements. (General Plastic Surgery/General Hospital) (Bench Testing)
- AAMI / ANSI / ISO 10993-1:2009/(R) 2013, biological s evaluation of medical devices -- Part 1: evaluation and testing within a risk management process. (Biocompatibility)
- ଦ ISO 11135 Second edition 2014, sterilization of health-care products - ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices. (Sterility)
- AAMI / ANSI / ISO 10993-7:2008(R) 2012, biological evaluation e of medical devices - part 7 : ethylene oxide sterilization residuals. (Sterility)

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Image /page/7/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized house or building. Below the shape, the word "med" is written in red cursive, and the word "COMP" is written in gray block letters.

1499 Delp Drive

Harleysville, PA 19438

Tel: [phone]

Fax. [phone]

www.medcompnet.com

Medcomp®: Vessel Dilator

- ISO 14971 Second edition 2007-03-01, medical devices e application of risk management to medical devices. (General I (QS/RM))
- Biocompatibility:

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Biocompatibility testing was performed on the final, finished, sterile device, Medcomp® Vessel Dilator (proposed) in accordance with ISO 10993-1. The Medcomp® Vessel Dilator (proposed) meets the requirements for limited, less than or equal to 24 hours, contact external communicating device with indirect blood contact. Biocompatibility studies were conducted by a testing facility that is ISO/IEC 17025 certified. GLP studies were conducted in accordance with the U.S. Food and Drug Administration Good Laboratory Practice (GLP) requlations set forth in 21 CFR part 58.

Summary of Substantial Equivalence:

In conclusion, the Vessel Dilators (proposed device) are substantially equivalent to the predicate (Merit® Medical Percutaneous Vessel Dilator, K801113) and reference device (Cook® Dilator, preamendment). Medcomp®'s Vessel Dilators (proposed device) are substantially equivalent to the reference device (Cook® Dilator, preamendment) in terms of intended use, anatomical location, basic design, performance, and labeling. Medcomp®'s Vessel Dilator (proposed device) are substantially equivalent to the predicate device's (Merit® Medical Percutaneous Vessel Dilator, K801113) instructions for use (labeling).

The proposed device, Vessel Dilators, meets the performance criteria of design verification as specified by ISO standards, quidance documents, and internal test protocols. Through testing, the additional product line made from polyethylene material, the proposed device. Vessel Dilators, are substantially equivalent to the indicated legally marketed reference device (Cook® Dilator, preamendment), and predicate device (Merit® Medical Percutaneous Vessel Dilator, K801113) as defined in the paragraph above.