BLUE MAX BALLOON DILATATION CATHETER

K071309 · Boston Scientific Corp · LIT · Jul 13, 2007 · Cardiovascular

Device Facts

• Record ID: K071309
• Device Name: BLUE MAX BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: LIT · Cardiovascular
• Decision Date: Jul 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Blue Max™ Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of the Iliac, Femoral, and Renal Arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Double lumen balloon dilatation catheter; non-compliant balloon mounted at distal tip; used to exert radial force to dilate narrow vessel segments; designed for calcified, fibrotic, or resistant lesions/strictures. Operates via guidewire tracking through central lumen; contrast medium infusion possible; balloon inflation lumen for radial expansion. Radiopaque markers facilitate positioning. Used in clinical settings by physicians; provides mechanical force to restore vessel patency; benefits patients by treating obstructive vascular disease.

Clinical Evidence

No clinical data; substantial equivalence based on identical materials and design characteristics to the predicate device.

Technological Characteristics

Double lumen catheter; non-compliant balloon; radiopaque markers for positioning; manual inflation via external source; Class II device (21 CFR 870.1250).

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty of iliac, femoral, or renal arteries, or treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Blue Max™ Balloon Dilatation Catheter (K000570)

Submission Summary (Full Text)

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K07/309

## 510(k) Summary

Per 21 CFR §807.92

JUL 1 3 2007

| Submitter's Name<br>and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and<br>Information | Kari Christianson<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared | May 07, 2006 |
| Proprietary<br>Name(s) | Blue MaxTM Balloon Dilatation Catheter |
| Common Name | Balloon Dilatation Catheter |
| Product Code | LIT |
| Classification of<br>Device | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Blue MaxTM Balloon Dilatation Catheter |
| Device<br>Description | The Blue MaxTM Balloon Dilatation Catheter, styled after the<br>Gruentzig technique, is a double lumen catheter with a non-<br>compliant balloon mounted at the distal tip. Dilatation<br>balloon catheters are used to exert radial force to dilate<br>narrow vessel segments. The Blue MaxTM balloon dilation<br>catheter is designed to deliver maximum force in calcified or<br>fibrotic lesions, or in lesions or strictures that are resistant to |
| Device | Catheter Construction |
| Description<br>(continued) | The Catheter body has two lumens. The lumen marked<br>"distal" is the central lumen of the catheter which terminates<br>at the distal tip. This lumen is used to pass the catheter over a<br>guidewire. The lumen can also be used for infusion of<br>contrast medium.<br><br>The lumen marked "Balloon" is the balloon inflation lumen.<br><br>The catheter shaft tapers beneath the balloon segment to<br>achieve the lowest possible deflated profile.<br><br>Radiopaque markers are placed under the balloon segment of<br>the catheter to provide visual reference points for balloon<br>positioning within the vessel. |
| Intended Use of<br>Device | Blue Max™ Balloon Dilatation Catheters are recommended<br>for Percutaneous Transluminal Angioplasty of the Iliac,<br>Femoral, and Renal Arteries and for the treatment of<br>obstructive lesions of native or synthetic arteriovenous<br>dialysis fistulae. |
| Comparison of<br>Technological<br>Characteristics | The materials and design of the Blue Max™ Balloon<br>Dilatation Catheter are equivalent to the predicate Blue Max<br>Balloon Dilatation Catheter. |
| Support of<br>Substantial<br>Equivalence | Boston Scientific Corporation considers the proposed Blue<br>Max™ Balloon Dilatation Catheter to be substantially<br>equivalent to the existing Blue Max™ Balloon Dilatation<br>Catheter (K000570 cleared April 13, 2000). This assessment<br>is based upon identical device materials and design<br>characteristics. The only change being initiated is to add a<br>contraindications section to the Directions for Use, and<br>move three existing precautions to this new section. |
| Conclusion | Based on the indications for use and the technological<br>characteristics, the Blue Max™ Balloon Dilatation Catheter<br>has been shown to be equivalent in intended use and is<br>considered to be substantially equivalent to the Blue Max™ |

## Balloon Construction

dilatation.

Each balloon inflates to its stated diameter and length over a range of 4 atm (405 kPa) to its rated burst pressure. The minimal dilating force required to dilate should be applied, minimizing risks of balloon over-inflation or rupture.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2007

Boston Scientific Corp. c/o Ms. Kari Christianson One Scimed Place A380 Maple Grove, MN 55311-1566

Re: K071309

Trade/Device Name: Blue Max™ Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter Regulatory Class: Class II (Two) Product Code: LIT Dated: May 7, 2007 Received: May 9, 2007

Dear Ms. Christianson:

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. Kari Christianson

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

R. bohner

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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## Indications for Use Statement

510(k) Number:

KO71309

Blue Max™ Balloon Dilatation Catheter Device Name:

Indications for Use:

Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of the Iliac, Femoral and Renal Arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Lochner

(Divic. Off)
Cardiovascular Devices

Number K071309

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