GELBFISH FLEX VASCULAR DILATOR

K030260 · Vascumetrix, LLC · DRE · Feb 20, 2003 · Cardiovascular

Device Facts

• Record ID: K030260
• Device Name: GELBFISH FLEX VASCULAR DILATOR
• Applicant: Vascumetrix, LLC
• Product Code: DRE · Cardiovascular
• Decision Date: Feb 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These devices are intended to be used over a guidewire to dilate or calibrate blood vessels.

Device Story

Gelbfish Flex Vascular Dilator is a vessel dilator used during percutaneous catheterization. Device is tracked over a guidewire to dilate or calibrate blood vessels. Operated by clinicians in a clinical setting. Modified from predicate to include a polyurethane shaft instead of stainless steel and utilizes medical grade adhesive for tip-to-shaft bonding instead of laser welding.

Clinical Evidence

Bench testing only.

Technological Characteristics

Vessel dilator for percutaneous catheterization. Features a polyurethane shaft and a tip bonded to the shaft using medical grade adhesive. Class II device.

Indications for Use

Indicated for use in patients requiring blood vessel dilation or calibration during percutaneous catheterization procedures.

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

• Gelbfish Vascular Dilators (K012256)

Submission Summary (Full Text)

{0}------------------------------------------------

030260

#### Summary of 510(k) Submission Section 11

FEB 2 0 2003

# 11.1 Type of Submission

Special 510(k) Date of Submission: January 9, 2003

# 11.2 Manufacturer

VascuMetrix, LLC 1058 N. Higley Rd. Suite 204 Mesa, AZ 85205 [phone] Fax: [phone]

Establishment Registration Number: 2032423 Owner/Operator Number: 9046947

# 11.3 Contact Person

Nick Raible President

### 11.4 Device

| 510(k) Number: | Not yet assigned |
|-------------------|-------------------------------------------------------------------------------------------------|
| Proprietary Name: | Gelbfish Flex Vascular Dilator |
| Generic Name: | Dilator, Vessel, For Percuteneous Catheterization |
| Classification: | Class II |
| Relevant Section: | 870.1310 |
| Product Code: | DRE |
| Intended Use: | These devices are intended to be used over a guidewire to<br>dilate or calibrate blood vessels. |

{1}------------------------------------------------

### 11.5 Predicate Device

| 510(k) Number: | K012256 |
|-------------------|-------------------------------------------------------------------------------------------------|
| Proprietary Name: | Gelbfish Vascular Dilators |
| Generic Name: | Dilator, Vessel, For Percuteneous Catheterization |
| Classification: | Class II |
| Relevant Section: | 870.1310 |
| Product Code: | DRE |
| Intended Use: | These devices are intended to be used over a guidewire to<br>dilate or calibrate blood vessels. |

## 11.6 Comparison to Predicate Device

- 1. The original 510(k) on these dilators limited the shaft material to stainless steel. The modified device has a polyurethane shaft.
- 2. The original device uses laser welding to bond the tip to the shaft. The modified device will use a medical grade adhesive to bond the tip to the shaft.

# 11.7 Conclusion

Comparison of the original device with the modified device for physical properties, performance characteristics and intended use, indicate that these devices are substantially equivalent and that there are no additional safety issues.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three abstract human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 2 0 2003

Mr. Nick Raible President VascuMetrix, LLC 1058 N Higley Rd., Suite 204 Mesa, AZ 85205

Re: K030260

> Trade/Device Name: Gelbfish Flex Vascular Dilator Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catherterization Regulatory Class: Class II Product Code: DRE Dated: January 8, 2003 Received: January 24, 2003

Dear Mr. Raible:

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

{3}------------------------------------------------

Page 2 - Mr. Nick Raible

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]. 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) you may obtain. 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 vours,

J.Q. Carter

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

Enclosure

{4}------------------------------------------------

Page of /

| 510(k) Number (if known): | K030260 |
|---------------------------|-------------------------------|
| Device Name: | Gelbfish Flex Vasalar Dilator |

Indications For Use:

#### Statement of Indented Use Section 2

These devices are intended to be used over a guidewire to dilate or calibrate blood vessels.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030260

Image /page/4/Picture/7 description: The image shows the words "Prescription Use" followed by the text "(Per 21 CFR 801.109)". There is a check mark above the text, indicating that the prescription use option has been selected. The text is in a simple, sans-serif font and is easy to read.

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)