MODIFICATION TO MEDAMICUS AXIA RSN

K022689 · Medamicus, Inc. · DYB · Aug 23, 2002 · Cardiovascular

Device Facts

• Record ID: K022689
• Device Name: MODIFICATION TO MEDAMICUS AXIA RSN
• Applicant: Medamicus, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 23, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The MedAmicus Axia RSN™ is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires, or similar devices.

Device Story

MedAmicus Axia RSN is a single-use catheter introducer featuring an integrated safety needle mechanism. Device facilitates percutaneous introduction of guidewires (up to 0.038 inches) into the body. Safety mechanism consists of a retractable needle; user pushes a button to retract needle into a protective shield prior to removal from the body, covering the needle tip to prevent accidental needle stick injuries. Used in clinical settings by healthcare professionals. Device is disposed of in sharps containers post-procedure. Benefits include reduced risk of occupational needle stick injuries for clinicians.

Clinical Evidence

Bench testing only. Design verification testing was conducted based on risk analysis per EN 1441 to evaluate the impact of material changes on device safety and effectiveness.

Technological Characteristics

Single-use catheter introducer; retractable needle safety mechanism; accommodates guidewires up to 0.038 inches; sterile; manual operation.

Indications for Use

Indicated for percutaneous introduction of guidewires or similar devices up to 0.038 inches in diameter, specifically designed to minimize needle stick injuries during the procedure.

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 Axia RSN (K020563)

Submission Summary (Full Text)

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MedAmicus, Inc.

Confidential

1622689

p.112

#### 510(k) Summary V.

Submitter

MedAmicus, Incorporated 15301 Highway 55 West Minneapolis, MN 55447 Main: 763-15301 Fax: [phone] email: www.medamicus.com

Date Prepared

August 10, 2002

Trade Name MedAmicus Axia RSN™

Common Name Catheter Introducer

Predicate Device

MedAmicus Axia RSN K020563

# Device Description

The MedAmicus Axia RSN™ is a single use device for percutaneous introduction of guidewires, or similar devices, up to 0.038 inches in diameter. The device is packaged as either sterile single units or as part of a kit. The device is designed with a shield as part of the safety needle mechanism to aid in the prevention of needle stick injuries. The needle of the device is retracted into the shield by pushing the button prior to removal of the device off the guidewire, or other device, and out of the body. After retraction, the shield covers the needle tip. The device is disposed of according to routine procedure in a sharps container.

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11022689

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# Intended Use

There are no changes to the Intended Use of the device from the currently approved device.

> The MedAmicus Axia RSN™ is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires, or similar devices.

# Technological Characteristics

The modified device is technologically equivalent to the currently approved device. The safety feature, which forms an integral part of this device, is a retractable needle mechanism that helps to minimize the risk of needle stick injuries.

### Summary of Studies

Design Verification has been completed to ensure that the modified material does not affect the safety and effectiveness of the device. The Design Verification Testing was completed based on a Risk Analysis per internal procedures that are compliant with EN 1441. The Risk Analysis was completed by comparing the risks associated with the material change to the original risks identified on the approved device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 23 2002.

MedAmicus, Inc. c/o Mr. Karyl Haskell Quality Assurance and Regulatory Affairs Manager 15301 Highway 55 West Minneapolis, MN 55447

Re: K022689

> MedAmicus Axia RSN™ Regulation Number: 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: 74 DYB Dated: August 12, 2002 Received: August 13, 2002

Dear Mr. 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.

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 (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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Page 2 - Mr. Karyl Haskell

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,

Elias Mells

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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Confidential

# VI. Indications for Use

.

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

Device Name: MedAmicus Axia RSN™

The MedAmicus Axia RSN™ is intended to minimize Indications for Use: needle stick injuries when used for percutaneous introduction of guidewires or other devices.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:flex; align-items:center;"> <span style="margin-right:5px;"></span> <span>✓</span> </div> | OR | Over-The-Counter Use | <span></span> |
|------------------|---------------------------------------------------------------------------------------------------------------|----|----------------------|---------------|
|------------------|---------------------------------------------------------------------------------------------------------------|----|----------------------|---------------|

| (Per 21 CFR 801.109) |
|----------------------|
|----------------------|

| | <div> Elias Malles </div> <div> (Division Sign-Off) </div> <div> Division of Cardiovascular </div> <div> and Respiratory Devices </div> |
|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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| 8 510(k) Number | k022689 |
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