VALVED PEELABLE INTRODUCER

K021004 · Medamicus, Inc. · DYB · Jun 6, 2002 · Cardiovascular

Device Facts

• Record ID: K021004
• Device Name: VALVED PEELABLE INTRODUCER
• Applicant: Medamicus, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jun 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The MedAmicus Valved Peelable Introducer is indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Device Story

The Valved Peelable Introducer is a percutaneous access device used by clinicians to implant pacing leads or catheters into the venous system. The device consists of a thin-wall PTFE sheath, a dilator, a guidewire, a needle, and a syringe. It features a sliding silicone valve integrated into a molded body; this valve allows for device insertion while minimizing blood loss and air intake. The sheath includes a 'tear-away' mechanism allowing removal of the introducer without disturbing the implanted lead or catheter. The device is provided sterile for single-use. By reducing air aspiration and blood loss during the procedure, the device facilitates safer venous access for cardiac pacing or catheterization.

Clinical Evidence

Bench testing only. Testing included valve pressure/vacuum flow rate reduction (demonstrating 78-99% reduction in air flow) and mechanical force testing (dilator/catheter insertion and removal forces, valve peeling force). All tests met pre-defined specifications. No clinical data was required or provided.

Technological Characteristics

Sheath: PTFE with bismuth trioxide radiopacifier. Handles: TPX resin. Dilator: HDPE with barium sulfate radiopacifier. Valve: Liquid silicone rubber. Coating: Parylene-N. Lubricant: Dow 360 Medical Fluid and Hexanes. Sizes: 7FR to 16FR. Sterilization: EtO. Connectivity: None (mechanical device).

Indications for Use

Indicated for percutaneous insertion of pacing leads or catheters into the venous system. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• MedAmicus Percutaneous Introducer (K932323)
• MedAmicus Percutaneous Introducer, Material Change (K000824)

Submission Summary (Full Text)

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KOZ1004

P1/6

edamicus
INCORPORATED

#### V. 510(k) Summary

### Submitter

MedAmicus, Incorporated

15301 Highway 55 West Minneapolis, MN 55447

Main: [phone] Fax: [phone]

### Submission Contact

Karyl Haskell Quality Assurance and Regulatory Affairs Manager [phone] [e-mail]

#### Date Prepared

February 28, 2002

Trade Name Valved Peelable Introducer

Common Name Catheter Introducer

#### Classification Name

Introducer, Percutaneous

#### Predicate Device

MedAmicus Percutaneous Introducer, K932323 MedAmicus Percutaneous Introducer, Material Change K000824

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# Device Description Information

#### Device Description

The MedAmicus Valved Peelable Introducer package consists of a thin-wall needle, a disposable syringe, and a flexible guidewire, packaged in a tray and a sealed nouch. Percutaneous introducers are small diameter tubular shaped devices with integrated proximal handles. The Valved Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system. The Valved Peelable Introducer has a "tear-away" feature common to the predicate devices. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead.

The Valved Peelable Introducer includes a sliding valve. When the valve is slid over the proximal end of the sheath, a device may be passed through the valve into the sheath, providing for reduced blood loss and reduced risk of air intake. The valve may be slid so that it is not covering the opening to the inner diameter of the sheath as well. The valve is constructed of a piece of silicon which snaps into a valve 'body' constructed of molded components.

#### Materials

The materials used in the manufacture of the Valved Peelable Introducer are identical to the materials used in the predicate device; with the exception of the valved portion of this introducer. All materials have been tested for biocompatibility.

The sheath body is constructed of PTFE and is filled with bismuth trioxide as a radiopacifier. The handles, made of TPX resin, are overmolded onto the PTFE sheath tubing. The dilator is made of HDPE resin filled with barium sulfate as a radiopacifier and has a HDPE hub overmolded onto the dilatory shaft.

The silicone part material is liquid silicone rubber. The permanent coating is parylene-N. The silicone lubricant, is a mixture of Dow 360 Medical Fluid and Hexanes.

The Valved Peelable Introducer will be packaged and EtO sterilized for one time use in a Tyvek pouch with a guidewire, needle and syringe. This configuration and specification remains the same as the configuration and specification that was previously cleared under K932323 and K000824.

The Polystyrene tray is commonplace in the medical industry as a packaging material for a number of medical devices. Biocompatability evaluations have

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been conducted along with sterility testing which demonstrate that this material is suitable as a tray material.

Appendix A contains photographs and engineering drawings of the Valved Peelable Introducer.

Appendix B contains a kit certification statement as required by FDA.

This percutaneous introducer has been modified from the introducer cleared under K932323. The material for the sliding valve portion of the introducer has been modified from polypropylene to silicone. The purpose of this change is to add the functionality of allowing a device to pass through the valve. The originally cleared product included a sliding valve that had to be slid out of the way when a device was inserted.

### Device Sizes

Sizes of the sheath and dilator range from 7FR to 16FR. The materials and construction are the same for all French sizes.

| French | Sheath Length |
|--------|---------------|
| | ±.50 |
| 7 | 5.93 |
| 7L | 5.86 |
| 8 | 5.93 |
| 9 | 5.93 |
| 10 | 5.93 |
| 11 | 5.93 |
| 12 | 5.93 |
| 13 | 5.93 |
| 14 | 5.53 |
| 15 | 5.53 |
| 16 | 5.53 |

### Intended Use

The Valved Peelable Introducer is indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.

## Technological Characteristics

The device is technologically equivalent to other introducers, including the valve mechanism to reduce blood loss and the risk of air intake.

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KO21004

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# Comparison to Predicate Device(s)

The Device Comparison Chart, Figure 1 below, shows that the Subject Device is equivalent to the two Predicate Devices. The Intended Use statements are identical and the design features are similar. The MedAmicus Valved Peelable Introducer is substantially equivalent to the MedAmicus Introducer Percutaneous, Valved, K932323, cleared November 9, 1993 in combination with the Material Change, Percutaneous Introducer K000824, cleared April 13, 2000.

| Subject<br>Device | Predicate<br>Device | Predicate<br>Device | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| MedAmicus Valved<br>Peelable Introducer | MedAmicus<br>Introducer,<br>Percutaneous, Valved<br>K932323 | MedAmicus Material<br>Change, Percutaneous<br>Introducer K000824 | |
| Intended Use | The MedAmicus Valved<br>Peelable Introducer is<br>intended for use in the<br>percutaneous insertion of<br>pacing leads or catheters<br>in the venous system. | The<br>MedAmicus<br>Percutaneou<br>s Introducer<br>is indicated<br>for use in<br>the insertion<br>of pacing<br>leads or<br>catheters in<br>the venous<br>system. | The MedAmicus<br>Percutaneous<br>Introducer is indicated<br>for use in the insertion<br>of pacing leads or<br>catheters in the venous<br>system. |
| Design<br>Features | PTFE<br>Introducer<br>sheath with<br>sliding valve<br>to reduce the<br>risk of blood<br>loss and<br>minimize the<br>risk of air<br>intake.<br>Devices may<br>be inserted<br>through the<br>valve. | Introducer<br>sheath with<br>a sliding<br>valve to<br>reduce the<br>risk of<br>blood loss<br>and air<br>aspiration | Introducer Sheath and<br>Dilator only |

### Device Comparison Chart

Figure 1

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### Summary of Studies

A Risk Analysis for the Valved Peelable Introducer was performed per MedAmicus' internal procedure, WI42020, Hazard Analysis, FMEA and Risk This document is modeled closely after European Standard Analysis. EN1441: 1998 Medical Devices - Risk Analysis.

The performance testing for this device included testing to verify that the valve portion functions per the design requirement. The remainder of the items (sheath, dilator, guidewire, syringe, and needle) have been tested under previously approved 510K's. The test results (see Figure 2 below) support the determination of substantial equivalence to the predicate device(s). This device will reduce the risk of blood loss and will minimize the risk of air intake. The following table includes the tests that have been conducted, the specifications of the tests and the results of each test:

| Test | Sample Size | Specification | Min | % Reduction<br>In Air Flow<br>compared to<br>he Introducer<br>with the valve<br>not closed<br>Mean | Max |
|--------------------------------|-------------|------------------------------------|----------|----------------------------------------------------------------------------------------------------|----------|
| Valve<br>Pressure<br>Flowrate | 30 | Valve must<br>reduce flow | 90% | 95% reduction<br>(before device<br>insertion) | 99% |
| | | | 78% | 86% reduction<br>(after<br>dilator/guidew<br>ire removal) | 94% |
| Valve<br>Vacuum<br>Flowrate | 29 | Valve must<br>reduce flow | 93% | 96% reduction<br>(before device<br>insertion) | 99% |
| | | | 80% | 88% reduction<br>(after dilator<br>/guidewire<br>removal) | 99% |
| | | | Force | Force | Force |
| Dilator<br>Insertion<br>Force | 29 | 2.0 lb.<br>maximum | 0.47 lb. | 0.66 lb. | 1.03 lb. |
| Dilator<br>Removal<br>Force | 29 | 2.0 lb.<br>maximum | 0.50 lb. | 0.74 lb. | 1.09 lb. |
| Catheter<br>Insertion<br>Force | 29 | 2.0 lb.<br>maximum | 0.56 lb. | 0.88 lb. | 1.09 lb. |
| Valve<br>Peeling<br>Force | 29 | Valve must<br>peel off<br>catheter | Pass | Pass | Pass |

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K621004 1.616

# 510(k) Summary Conclusion

Medamicus belives that the MedAmicus Valved Peelable Introducer is substantially equivalent to the predicate MedAmicus Percutaneous Introducer kits. The intended use, materials, sterilization, packaging, labeling, method of operation and manufacturing methods have been proven to be identical.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 6 2002

MedAmicus, Incorporated c/o Ms. Karyl D. Haskell Ouality Assurance and Regulatory Affairs Manager 15301 Highway 55 West Minneapolis, MN 55447

Re: K021004 Trade Name: Valved Peelable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: 74 DYB Dated: March 27, 2002 Received: March 28, 2002

Dear Ms. Haskell:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Karyl D. Haskell

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Elia Mallia

for

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# VII. Indications for Use

510(k) Number (if known): Not Assigned

Device Name: MedAmicus Valved Peelable Introducer

The MedAmicus Valved Peelable Introducer is Indications for Use: intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Olia Mallia

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K021004 1:0(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use______________

(Per 21 CFR 801.109)

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