INSCOPE 3-STAGE BALLOON DILATOR

K043605 · Cordis Europa, N.V. · KNQ · Feb 4, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K043605
• Device Name: INSCOPE 3-STAGE BALLOON DILATOR
• Applicant: Cordis Europa, N.V.
• Product Code: KNQ · Gastroenterology, Urology
• Decision Date: Feb 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5365
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InScope Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus

Device Story

InScope Precision Balloon Dilator is a sterile, single-use, disposable esophageal dilator. Device features three radiopaque marking bands on the balloon to facilitate precise centering within strictures; middle band at balloon center, proximal and distal bands 2.5 cm from center. Includes stopcock to maintain pressure or vacuum. Device provides three distinct, progressive diameters based on applied inflation pressure; specific pressure/diameter relationships provided on labeling. Used by physicians in clinical settings during endoscopic procedures to dilate esophageal strictures. Benefits include mechanical dilation of narrowed esophageal segments to improve patient swallowing and esophageal function.

Clinical Evidence

Bench testing only. Safety and effectiveness demonstrated via non-clinical bench tests and analyses. Materials confirmed to be biocompatible.

Technological Characteristics

Sterile, single-use, disposable esophageal balloon dilator. Features three marking bands for positioning. Includes stopcock for pressure/vacuum maintenance. Capable of three progressive diameters based on inflation pressure. Biocompatible materials.

Indications for Use

Indicated for endoscopic dilation of esophageal strictures in adult and adolescent populations.

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's CRE Balloon dilatation catheter

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for Cordis, a Johnson & Johnson company. The word "Cordis" is written in a bold, sans-serif font, with a thick line underlining it. Below the line, the text "a Johnson-Johnson company" is written in a smaller, italicized font. The logo is simple and professional, reflecting the company's corporate identity.

# Appendix B

| | 510 (k) Summary of Safety and Effectiveness |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's<br>name and<br>address | Cordis Europa, NV<br>Oosteinde 8<br>NL-9301 LJ Roden<br>The Netherlands |
| Contact<br>Person | Harm Hovinga<br>Senior Regulatory Affairs Associate<br>Tel: +31 - (5050) 22479<br>Fax: +31 - (5050) 22456<br>E-mail: [e-mail]) |
| Date prepared | December 23, 2004 |
| Device Trade<br>Name | InScope Precision balloon Dilator |
| Common<br>Name | Esophageal dilator |
| Classification<br>Name | KNQ (21 CFR 876.5365 Esophageal dilator |
| Device<br>Classification | Class II. |
| Performance<br>standards | FDA has not (yet) established specific performance standards for this device<br>under section 514 of the Food, Drug and Cosmetic Act. |

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Image /page/1/Picture/1 description: The image shows the logo for Cordis, a Johnson & Johnson company. The word "Cordis" is written in a bold, sans-serif font, with a thick line underlining it. Below the line, in a smaller, more cursive font, it says "a Johnson & Johnson company."

| Product<br>Description | The InScope Precision Balloon Dilator is a sterile, single use, disposable<br>esophageal dilator. The InScope Precision Balloon Dilator contains three<br>marking bands on the balloon to facilitate more precise centering the balloon<br>within the stricture. The middle band is located at the center of the balloon at<br>5 cm distance from the shaft marker. The proximal and distal bands are set<br>2.5 cm from the centre band. The InScope Precision Balloon Dilator is<br>provided with a stopcock to maintain pressure or vacuum. The InScope<br>Precision Balloon Dilator is capable of 3 distinct and progressive larger<br>diameters as a function of the applied inflation pressure. The specific pressure<br>/ diameter relationship is represented on the labeling of each product.<br>The subject InScope Precision Balloon Dilator described in this submission is<br>virtually identical to its predicate device (Boston Scientific's CRE Balloon<br>dilatation catheter), which already has received FDA 510(k) concurrence. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The InScope™ Precision Balloon Dilator is intended for use in adult and<br>adolescent populations to endoscopically dilate strictures of the esophagus. |
| Technological<br>comparison | Comparisons of the subject and the predicate device(s) show that<br>technological characteristics, such as materials, mode of operation,<br>performance properties, biocompatibility, sterilization and packaging are<br>considered substantially equivalent to the currently marketed predicate<br>devices, |
| Performance<br>Data | The safety and effectiveness of the InScope Precision Balloon Dilator has<br>been demonstrated via data collected from non-clinical bench type tests and<br>analyses. The materials used in the subject device are found to be<br>biocompatible. |

Substantial Equivalence Statement

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from Johnson compan

A statement of substantial equivalence to another product is required by 21 CFR 807.87 and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any I ne present submission interpreted as an admission or used as evidence in patcht and is not to be interpt. As the commissioner of the FDA stated: a patche mirringencere lastantial equivalence under the Federal Food, Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without pre-market approval or reclassification. The determination is not intended to have any bearing whatsoever on the deter infringement suits." 42 Federal Register 42, 50 et seq. (1977).

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FEB - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Harm Hovinga Senior Regulatory Affairs Associate Cordis Corporation, A Johnson & Johnson Company Cordis Europa N.V. Oosteinde 8 9301 LJ Roden, Drenthe THE NETHERLANDS

Re: K043605

Trade/Device Name: InScope" Precision Balloon Dilator Regulation Number: 21 CFR §876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: 78 KNO Dated: December 23, 2004 Received: December 30, 2004

Dear Mr. Hovinga:

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 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 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.

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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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmadsmam.html

Sincerely vours.

Nancy C. brogdon
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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Cordis Franchise Form - CFF 20-014 Rev.01 Intended Use Statement

Page 1 of 1 Effective Date: 11/15/00

Image /page/5/Picture/2 description: The image shows the logo for Cordis, a Johnson & Johnson company. The word "Cordis" is written in a bold, sans-serif font, with a thick line underneath it. Below the line, the words "a Johnson & Johnson company" are written in a smaller, cursive font. The logo is simple and professional, and it clearly identifies the company.

## Appendix A: Intended Use Statement

Page 1 of 1

510(k) Number (if known): K043605

Device Name:

#### InScope™ Precision Balloon Dilator

#### Indications for Use Statement

The InScope Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span style="font-size: 2em;">✓</span> </div> | OR | Over-The-Counter Use |
|------------------|-----------------------------------------------------|----|----------------------|
|------------------|-----------------------------------------------------|----|----------------------|

| (Division Sign-Off) | <div> Nancy C Brogdon </div> |
|---------------------------------------------------------------|-------------------------------------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K043605 |