MAXFORCE TTS SINGLE-USE BALLOON DILATOR

K061787 · Boston Scientific Corp · KNQ · Sep 21, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061787
• Device Name: MAXFORCE TTS SINGLE-USE BALLOON DILATOR
• Applicant: Boston Scientific Corp
• Product Code: KNQ · Gastroenterology, Urology
• Decision Date: Sep 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5365
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Boston Scientific Corporation Maxforce TTS Single-Use Balloon Dilator is indicated for use in adults and adolescent populations to endoscopically dilate strictures of the esophagus.

Device Story

Maxforce TTS Single-Use Balloon Dilator is an endoscopic device used by physicians to dilate esophageal strictures. The device consists of a distal tip, balloon, catheter shaft, and proximal hub. It is inserted endoscopically to the site of the stricture; the balloon is then inflated to mechanically dilate the narrowed esophageal passage. This procedure is performed in a clinical setting to improve patient swallowing and esophageal function. The device is intended for single use.

Clinical Evidence

Bench testing only; physical comparison to the predicate device supports the determination of substantial equivalence.

Technological Characteristics

Single-use balloon dilation catheter comprising a distal tip, balloon, catheter shaft, and proximal hub. Operates via mechanical balloon inflation for endoscopic dilation. Class II device (21 CFR 876.5365).

Indications for Use

Indicated for adults and adolescents to endoscopically dilate esophageal strictures. Contraindicated in patients with acute or incompletely healed esophageal perforation, severe coagulopathy, acute severe abdominal symptoms, or deeply ulcerated stenosis.

Regulatory Classification

Identification

An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Boston Scientific Maxforce TTS Single-Use Balloon Dilator (K934697)

Submission Summary (Full Text)

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K061787 Page 1 of 2

# SEP 2 1 2006

# 510 (k) SUMMARY

| SPONSOR: | Boston Scientific Corporation<br>100 Boston Scientific Way<br>Marlborough, MA 01752 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Wing Ng<br>Regulatory Affairs Specialist<br>Boston Scientific Corporation<br>100 Boston Scientific Way<br>Marlborough, MA 01752<br>Tel: [phone]<br>Fax: [phone]<br>Date Prepared: June 23, 2006 |
| DEVICE: | |
| Trade Name: | Maxforce TTS Single-Use Balloon Dilator |
| Common Name: | Balloon Dilation Catheter |
| Classification: | Class II, per 21 CFR Part 876, Section 5365 |
| PREDICATE DEVICE: | Boston Scientific Maxforce TTS Single-Use Balloon<br>Dilator (K934697). |

DEVICE DESCRIPTION: The Maxforce TTS Single-Use Balloon Dilator consists
of a distal tip, balloon, catheter shaft, and proximal hub.

| INTENDED USE: | The Boston Scientific Corporation Maxforce TTS<br>Single-Use Balloon Dilator is indicated for use in adults<br>and adolescent populations to endoscopically dilate<br>strictures of the esophagus. |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

DESCRIPTION OF
CHANGE FOR THIS
SUBMISSION:
The purpose of this premarket notification is to add four
new contraindications to the Directions for Use of this
device. The four new contraindications are as follows:
➤ Acute or incompletely healed perforation of the
esophagus.
➤ Severe coagulopathy.

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061787

ge 2 of 2

- > Acute severe abdominal symptoms.
- > Deeply ulcerated stenosis.

#### COMPARISON OF CHARACTERISTICS:

The proposed device is substantially equivalent to the currently marketed device, as they have the same fundamental design, operating principal, materials, and intended use.

PERFORMANCE DATA: FDA's "Guidance for the Content of Premarket Notifications", and the results of physical comparison support a determination of substantial equivalence for the proposed device when compared to the predicate device.

#### SUBSTANTIAL EQUIVALENCE:

The proposed Maxforce TTS Single-Use Balloon Dilator is substantially equivalent to the predicate Maxforce TTS Single-Use Balloon Dilator (K934697).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a flame.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 2 1 2006

Mr. Wing Ng Regulatory Affairs Specialist Boston Scientific Corporation Endoscopy 100 Boston Scientific Way MARI-BOROUGH MA- 01752

Re: K061787

Trade/Device Name: Maxforce TTS Single-Use Balloon Dilator Regulation Number: 21 CFR 8876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: KNQ Dated: August 22, 2006 Received: August 23, 2006

Dear Mr. Ng:

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 ass battle and 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 (Premarket 11 your al), it may be subject to such additional controls. Existing major regulations affecting your r ipply rary 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are stars surrounding the text at the bottom of the logo. The logo appears to be a commemorative emblem for the FDA's centennial anniversary.

Promoting Public 9

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Page 2 -

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 teller with allow your 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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K061787

Special 510(k) Premarket Notification Maxforce™ TTS Single-Use Balloon Dilator Boston Scientific Corporation June 23, 2006

# INDICATIONS FOR USE STATEMENT

| 510(k) Number | To be determined |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Maxforce TTS Single-Use Balloon Dilator |
| Indications For Use | The proposed Maxforce TTS Single-Use Balloon Dilator is indicated for use in adults and adolescent populations to endoscopically dilate strictures of the esophagus. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

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

(Division Sign-Off) Division of Reproductive, Al and Radiological Devices 510(k) Number .

Proprietary and Confidential Information of Boston Scientific Corporation