OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR

K031147 · Ethicon Endo-Surgery, Inc. · KNQ · Jan 12, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K031147
• Device Name: OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: KNQ · Gastroenterology, Urology
• Decision Date: Jan 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5365
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Optical DVS (Dual Vector Shearing) Esophageal Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.

Device Story

Optical DVS is a sterile, single-use, disposable esophageal dilator. Device consists of a clear flexible polymer tube designed to accommodate an endoscope (10mm diameter or less). During clinical use, endoscope is inserted into the dilator to provide direct visualization of the esophageal stricture site while the dilator performs the mechanical dilation. Device allows clinicians to visualize the stricture during the procedure, unlike traditional non-visualized dilators. Benefits include improved procedural guidance and accuracy during esophageal stricture management.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Clear flexible polymer. Form factor: Tubular dilator for use with endoscopes up to 10mm diameter. Energy source: None (mechanical). Sterilization: Sterile, single-use.

Indications for Use

Indicated for dilation of esophageal strictures under endoscopic visualization in patients requiring esophageal dilation.

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

• Savary-Gilliard Dilators (K851955)

Submission Summary (Full Text)

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# JAN 1 2 2004

K031147

Page 1 of 1

# Optical DVS (Dual Vector Shearing) Esophageal Dilator 510(k) Summary of Safety and Effectiveness

## Company

Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242

## Contact

Kimberly Shoemaker Senior Regulatory Affairs Associate

## Date Prepared:

April 8, 2003

### Name of Device

Trade Name: Optical DVS (Dual Vector Shearing) Esophageal Dilator Classification Name: Esophageal Dilator

## Predicate Devices:

Savary-Gilliard Dilators cleared under K851955 on 07/25/85

## Device Description

The Optical DVS is a sterile, single use, disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical DVS is made from a clear flexible polymer. An endoscope having an outer diameter of 10mm or less, such as a standard gastroscope, is positioned within the Optical DVS to allow for visualization at the stricture site.

## Indications for Use

The Ontical DVS is indicated for dilation of strictures of the esophagus under endoscopic visualization.

### Technological Characteristics

The Optical DVS is similar to the predicate device with respect to design. The Optical DVS allows for visualization of strictures with the use of an endoscope where as the predicate device does not.

## Performance Data

Bench testing was performed to verify dilation performance. These data, combined with descriptive intended use and design information, indicate the Optical DVS is substantially equivalent to the Savary-Gilliard Dilator.

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JAN 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kimberly Shoemaker Sr. Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. A Johnson & Johnson Co. 4545 Creek Road CINCINNATI OH 45242-2839

Re: K031147

Trade/Device Namc: OPTICAL DVS (Dual Vector Shearing) Esophageal Dilator Regulation Number: 21 CFR §876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: 78 KNQ Dated: October 13, 2003 Received: October 14, 2003

Dear Ms. Shoemaker:

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 usc 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 Fedcral 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 (sec 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 Fedcral 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 practicc 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 his letter will anow you to begin hantes of substantial equivalence of your device to a legally prematication. The PDF intems to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your do the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions on increase note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general by reference to premarked nonitode (21 cm 4ct may be obtained from the Division of Small information on your responsionalises and consumer Assistance at its toll-free number [phone] or Manufacturers, International and Collection 115-11-11-11-11-11-11-11-11-11-11-11

Sincerely yours,

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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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: OPTICAL DVS (Dual Vector Shearing) Esophageal Dilator

Indications for Use:

The Optical DVS (Dual Vector Shearing) Esophageal Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)