INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED

K060302 · Cordis Europa, N.V. · KNQ · Apr 11, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060302
• Device Name: INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
• Applicant: Cordis Europa, N.V.
• Product Code: KNQ · Gastroenterology, Urology
• Decision Date: Apr 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5365
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InScope Precision Balloon Dilator - Wire Guided - with pre-loaded 0.035" guide wire - Is a sterile, single use, disposable dilator used in the alimentary tract (esophagus, pylorus and colon). In the sterile product packaging also a stopcock is provided to maintain pressure or vacuum by an inflation device. The balloon specific pressure / diameter relationship is represented on the labeling of each product. The InScope Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract (i.e. esophagus, pylorus and colon).

Device Story

InScope Precision Balloon Dilator is a sterile, single-use, wire-guided device for endoscopic dilation of alimentary tract strictures. Device includes a pre-loaded 0.035" guide wire and a stopcock for pressure/vacuum maintenance via an external inflation device. Operated by physicians in clinical settings during endoscopic procedures. Physician monitors balloon inflation via endoscopic visualization and pressure/diameter labeling to dilate strictures. Benefits include mechanical relief of alimentary tract obstructions.

Clinical Evidence

Bench testing only. Performance demonstrated via non-clinical bench tests and analyses. Materials confirmed as biocompatible.

Technological Characteristics

Sterile, single-use, disposable balloon dilator. Includes pre-loaded 0.035" guide wire and stopcock. Mechanical dilation principle. Biocompatible materials. Sterilized. No software or electronic components.

Indications for Use

Indicated for endoscopic dilation of alimentary tract strictures (esophagus, pylorus, colon) 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

• InScope Precision Balloon Dilator - Fixed Wire
• Boston Scientific's CRE Wireguided Balloon Dilator

Submission Summary (Full Text)

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KA60302
Page 1 of 3

## APR 1 1 2006

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# Appendix B

## 510 (k) Summary

| 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 | April 3, 2006. |
| Device Trade<br>Name | InScope™ Precision Balloon Dilator - Wire Guided |
| 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. |
| Product | The subject InScope Precision Balloon Dilator - Wire Guided described in |

Product this submission is virtually identical to its predicate device(s), which already Description have received 510(k) concurrence.

00058

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| | Intended Use | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | The InScope Precision Balloon Dilator - Wire Guided - with pre-loaded<br>0.035" guide wire - Is a sterile, single use, disposable dilator used in the<br>alimentary tract (esophagus, pylorus and colon). In the sterile product<br>packaging also a stopcock is provided to maintain pressure or vacuum by an<br>inflation device.<br>The balloon specific pressure / diameter relationship is represented on the<br>labeling of each product. | |
| | Compared to the previously cleared predicate device - InScope Precision<br>Balloon Dilator - Fixed Wire, the subject InScope Precision Balloon Dilator -<br>Wire Guided in this submission now resembles the Boston Scientific's CRE<br>Wireguided Balloon Dilator, which already received FDA 510(k)<br>concurrence. | |
| | The InScope Precision Balloon Dilator is intended for use in adult and<br>adolescent populations to endoscopically dilate strictures of the alimentary<br>tract (i.e. esophagus, pylorus and colon). | |
| 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 performance of the InScope Precision Balloon Dilator - Wire Guided has<br>been demonstrated via non-clinical bench type tests and analyses. The results<br>from these tests are documented in detail in Section 6 -Performance Testing<br>of this submission. The materials used in the subject device are found to be<br>biocompatible. | |

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### Substantial Equivalence Statement

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 patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the commissioner of the FDA stated: "A determination of substantial 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 resolution of patent infringement suits." 42 Federal Register 42, 50 et seq. (1977).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

APR 1 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Harm Hovinga Senior Regulatory Affairs Associate Cordis Europa N.V. Oosteinde 8 NL-9301 LJ Roden THE NETHERLANDS

Re: K060302

Trade/Device Name: InScope™ Precision Balloon Dilator- Wire Guided Regulation Number: 21 CFR §876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: KNQ Dated: February 3, 2006 Received: February 6, 2006

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 (Premarket Approval), 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 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) I ms letter will and in your finding of substantial equivalence of your device to a legally premation notification - rives 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 11 you dobt 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 Anot, production other general information on your responsibilities under the Act from the 601:37). I od may ookin surers, 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,

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

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#### Intended Use Statement Appendix A:

Page 1 of 1

K060302 510(k) Number (if known):

Device Name:

## InScope™ Precision Balloon Dilator - Wire Guided

### Indications for Use Statement

The InScope Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract (i.e. esophagus, pylorus and colon).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <svg height="15" width="15"> <path d="M3 7 L7 11 L12 4" fill="none" stroke="black" stroke-width="2"></path> </svg> </div> |
|------------------|---------------------------------------------------------------------------------------------------------------------------------|
| | OR |
| | Over-The-Counter Use ________ |


(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K060302 |
|---------------|---------|
|---------------|---------|