PBN GUIDEWIRES

K031442 · Medical Device Technologies, Inc. · DQX · Aug 13, 2003 · Cardiovascular

Device Facts

• Record ID: K031442
• Device Name: PBN GUIDEWIRES
• Applicant: Medical Device Technologies, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The PBN Guidewires are intended for use to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Device Story

PBN Guidewires consist of a stainless steel or nitinol core wire with a stainless steel or tungsten spring; available uncoated, hydrophilic coated, or PTFE coated. Diameters range .018 in. to .020 in.; lengths 40 cm to 300 cm. Device functions as a mechanical guide to facilitate percutaneous catheter navigation through blood vessels. Used by clinicians in cardiovascular procedures. Output is physical guidance of the catheter; assists in precise vessel access. Benefits include improved catheter trackability and navigation.

Clinical Evidence

Bench testing only. Testing included tensile strength, torqueability, tip flexibility, and coating adherence/integrity. Results demonstrated performance comparable to the predicate device.

Technological Characteristics

Materials: Stainless steel or nitinol core, stainless steel or tungsten spring. Coatings: Uncoated, hydrophilic, or PTFE. Dimensions: .018-.020 in. diameter, 40-300 cm length. Mechanical device; no energy source or software.

Indications for Use

Indicated for use in patients requiring percutaneous catheterization to direct a catheter through a blood vessel.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Microvenia Corporation Guidewires (K991898)

Submission Summary (Full Text)

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K031442

Image /page/0/Picture/11 description: The image is a logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is in black and white, with the text "MDTECH" in large, bold letters. Below the text is the phrase "MEDICAL DEVICE TECHNOLOGIES INC" in smaller letters. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials.

600 SW 47th Avenue iainesville, Florida 32608 AUG 1 3 2003

| TEL: [phone] FAX: [phone] | | |
|-------------------------------------|-----------------------------------------------------------------------------------|------------|
| | 510(k) SUMMARY | |
| APPLICANT: | Medical Device Technologies, Inc.<br>3600 SW 47th Avenue<br>Gainesville, FL 32608 | |
| CONTACT: | Karl Swartz<br>Quality Assurance Manager | |
| TELEPHONE: | [phone]<br>fax [phone] | |
| TRADE NAMES: | PBN Guidewires | |
| COMMON NAME: | Guidewires | |
| CLASSIFICATION NAME: | Wire, Guide, Catheter, CFR 870.1330 | |
| PRODUCT CODE: | DQX | |
| PANEL: | Cardiovascular | |
| SUBSTANTIAL EQUIVALENCE: | | |
| Company Name | Product Name | 510(k) No. |

### DESCRIPTION OF DEVICE:

Microvenia Corporation

The PBN Guidewires are made from a stainless steel or nitinol core wire surrounded by a stainless steel or tungsten spring. The PBN Guidewires will be provided uncoated, hydrophilic coated, or PTFE coated. The PBN Guidewires will be provided in the following diameters and lengths: .018 in. and .020 in. diameter, and 40 cm to 300 cm in length.

K991898

Guidewires

# INDICATIONS FOR USE:

The PBN Guidewires are intended for use to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

### FUNCTIONAL & SAFETY TESTING:

The PBN guidewires were subjected to tensile strength, torqueability, tip flexibility, and coating adherence/integrity tests. The results of the testing indicated that they are comparable to the predicate device.

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K031442

Image /page/1/Picture/1 description: The image shows the logo for MD Tech Medical Device Technologies Inc. The logo is in black and white, with the letters "MD TECH" in large, bold font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC" in a smaller font. The logo is enclosed in a rectangular box with rounded corners.

`600 SW 47th Avenue iainesville, Florida 32608 TEL: [phone] FAX: [phone]

# TECHNICAL COMPARISON:

The following attributes of the PBN guidewire were examined and found to be comparable to the predicate device:

- Intended size 1.
- 2. Length
- Distal end configuration 3.
- Intended anatomical location of distal end 4.
- ર . Proximal end configuration
- Materials 6.
- Labeling 7.

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the people.

Public Health Service

AUG 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Device Technologies, Inc. c/o Mr. Karl Swartz 3600 S. W. 47th Avenue Gainesville, FL 32608

Re: K031442

PBN Guidewires Regulation Number: 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: May 2, 2003 Received: May 19, 2003

Dear Mr. Swartz:

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. Iisting 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 - Mr. Karl Swartz

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. 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

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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Image /page/4/Picture/0 description: The image is a logo for MDTECH Medical Device Technologies INC. The logo is black and white and features the letters "MDTECH" in large, bold font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC" in a smaller font. The logo is rectangular with rounded corners.

7600 SW 47th Avenue Jainesville, Florida 32608 TEL: [phone] FAX: [phone]

Page_1_of_1

510(k) Number (if known):____K 031442_

Device Name: PBN Guidewires

Indications for Use:

The PBN Guidewires are intended for use to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96

MCQTM

510(k) Num