GELBISH VASCULAR DILATOR

K012256 · Vascumetrix, LLC · DRE · Dec 20, 2001 · Cardiovascular

Device Facts

• Record ID: K012256
• Device Name: GELBISH VASCULAR DILATOR
• Applicant: Vascumetrix, LLC
• Product Code: DRE · Cardiovascular
• Decision Date: Dec 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VascuMetrix Gelbfish™ Vascular Dilators are to be used over a guidewire to dilate or calibrate blood vessels.

Device Story

Gelbfish™ Vascular Dilator is a single-use, sterile device designed for percutaneous catheterization or surgical cutdown procedures. It consists of a stainless steel tube with a welded stainless steel tip, available in ten sizes. The device is operated by physicians using sterile technique. It is threaded over a 0.035" guidewire to mechanically dilate or calibrate the lumen of a blood vessel. By providing a controlled increase in vessel diameter, the device assists in preparing the vessel for subsequent interventional procedures, potentially improving procedural success and patient outcomes.

Clinical Evidence

Bench testing only. Physical testing demonstrated that the device meets performance requirements for strength and flexibility comparable to the predicate device.

Technological Characteristics

Materials: Stainless steel. Design: Tubular body with welded tip, compatible with 0.035" guidewires. Form factor: Available in ten sizes. Sterilization: Sterile, single-use. Energy source: None (mechanical).

Indications for Use

Indicated for use by physicians to dilate or calibrate blood vessel lumens via percutaneous catheterization or surgical cutdown. Requires use over a 0.035" guidewire.

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

• Peripheral Vascular Dilator (K974617)

Submission Summary (Full Text)

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# DEC 2 0 2001

K012256

1

# Summary of 510(k) Submission

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VascuMetrix 2824 N. Power Rd. Suite 113-278 Mesa, AZ 85215

Tel: [phone] Fax: [phone]

### Contact Person 1.1

Mike Hammons Director of Operations

#### Manufacturer 1.2

## VascuMetrix, LLC

2824 N. Power Rd. Suite 113-278 Mesa, AZ 85215 Phone: [phone] Fax: [phone]

### Type of Submission 1.3

Traditional 510(k) Date of submission: August 10, 2001 Date of revision: November 1, 2001

#### 1.4 Device

| 510(k) Number: | K012256 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Gelbish™ Vascular Dilator |
| Common/Generic Name: | DILATOR, VESSEL, FOR PERCUTENEOUS<br>CATHETERIZATION |
| Classification: | Class II |
| Relevant section: | 870.1310 |
| Product Code: | DRE |
| Intended Use: | The VascuMetrix Gelbfish™ Vascular Dilators are to<br>be used over a guidewire to dilate or calibrate blood<br>vessels. |

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# 1.5 Predicate Device

| 510(k) Number: | K974617 |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| Device Name: | Peripheral Vascular Dilator |
| Manufacturer: | EndoVascular Instruments, Inc. |
| Common/Generic Name: | DILATOR, VESSEL, FOR PERCUTENEOUS<br>CATHETERIZATION |
| Classification: | Class II |
| Relevant section: | 870.1310 |
| Product Code: | DRE |
| Intended Use: | The EndoVascular Instrument Peripheral Vascular<br>Dilator is intended to be used to enlarge or calibrate<br>vessel. |

#### Description of the device 1.6

The VascuMetrix Gelbfish™ Vascular Dilators consist of a small diameter stainless steel tube with a smooth stainless steel tip welded to one end. The lumen of the tube sicer tube with a slide over an 0.035" guidewire. The tips are available in ten sizes and can be used to dilate or calibrate the lumen of a blood vessel.

The dilator can be inserted into a blood vessel either through a surgical cutdown or I he unator can of inserted int for use only by physicians using sterile technique. It is shipped sterile and intended as a single use device.

### Comparison to the Predicate Device 1.7

The physical chemistry, wall thickness, temper, nominal tensile strength and % The physical chemisury, wan thickless, temper, nominal was results of the really crongation of the share of are constructed of identical matterial and the shapes are predicate device. The strength of the Gelbfish™ Vascular Dilators is equal to or greater than that of the predicate device.

Physical testing has demonstrated that the Gelbfish™ Vascular Dilators and the I hyslour cosing has desimilar flexibility characteristics and are both adequately predicals device have simmal nextonity only and issues of the Vascular Dilators pose no new safety or efficacy issues.

The indications for use are identical.

#### Conclusion: 1.8

Comparison of the Gelbfish™ Vascular Dilators to EndoVascular Instrument's Comparison of the Golonial
Peripheral Vascular Dilator for physical properties, performance characteristics and intended use, indicate that these devices are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure. The text is in all caps and arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2001

Mr. Mike Hammons Director of Operations VascuMetrix, LLC 2824 N. Power Rd. Suite 113-278 Mesa, AZ 85215

Re: K012256

> Trade Name: Gelbish™ Vascular Dilator Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catherization. Regulatory Class: II Product Code: DRE Dated: August 10, 2001 Received: August 13, 2001

Dear Mr. Hammons:

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

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## Page 2 - Mr. Mike Hammons

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 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,

Dr. Bram Zuckerman, M.D.

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Statement of Intended Use Section 4

510(k) Number: K012256

Device Name: Gelbfish™ Vascular Dilator

Indications for Use:

The VascuMetrix Gelbfish™ Vascular Dilators are to be used over a guidewire to dilate or calibrate blood vessels.

iratory D

Division of Cardiovascular & Respiratory Devices
510(k) Number K012356

Prescription Use
(Per 21 CFR 801.109)