JACKSON ESOPHAGEAL DILATOR

K990935 · Pilling Weck Surgical · KNQ · May 17, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990935
• Device Name: JACKSON ESOPHAGEAL DILATOR
• Applicant: Pilling Weck Surgical
• Product Code: KNQ · Gastroenterology, Urology
• Decision Date: May 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5365
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used for exploration and dilation of strictures of the esophagus. Designed to be used in conjunction with an appropriate size rigid esophagascope.

Device Story

Jackson Esophageal Dilator is a manual surgical instrument used for the exploration and dilation of esophageal strictures. The device is operated by a physician in a clinical setting, typically in conjunction with a rigid esophagoscope. It consists of a silicone tip, a stainless steel rod, and a nylon sleeve. The device functions mechanically to physically dilate strictures, aiding in the treatment of esophageal narrowing. It does not involve electronic components, software, or automated processing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical instrument. Materials: silicone tip, stainless steel rod, nylon sleeve. Form factor: rod-based dilator. No energy source, connectivity, or software. Sterilization method not specified.

Indications for Use

Indicated for exploration and dilation of esophageal strictures in patients requiring such procedures, to be used with a rigid esophagoscope.

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

• Jackson Esophageal Dilator made with Cyanoacrylate

Submission Summary (Full Text)

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K990935 p.1/1

MAY 17 1999

## 510(K) Summary

#### 1. Submitter Name, Address, and Date of Submission.

Elizabeth Lazaro Pilling Weck Surgical 420 Delaware Drive Fort Washington, PA 19034 Telephone Number

[phone] [phone] Fax

Contact: Same as above.

## 2. Name of the Device, Common, Proprietary (if known), and Classification.

Classification Name: Common Name: Proprietary Name: Class I Device

Esophageal Dilator Esophageal Dilator Jackson Esophageal Dilator

- 3. Identification of the legally marketed device to which the submitter claims equivalence.
Jackson Esophageal Dilator made with Cyanoacrylate.

## 4. Description of the Device. Device consists of silicone tip, stainless steel rod and nylon sleeve.

## 5. Intended Use of the Device.

To be used for exploratory and dilation of strictures of the esophagus.

### 6. Summary of Technological Characteristics. The technological characteristics are the same as, or equivalent to the Jackson

Esophageal Dilator.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 1999

Ms. Elizabeth Lazaro Pilling Weck Surgical 420 Delaware Drive Fort Washington, Pennsylvania 19034 Re: K990935 Jackson Esophageal Dilator Dated: March 17, 1999 Received: March 19, 1999 Regulatory Class: Il 21 CFR 876.5365/Procode: 78 KNQ

Dear Ms. Lazaro:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known): K990935

Device Name: Jackson Esophageal Dilators

Indications for Use:

To be used for exploration and dilation of strictures of the esophagus. Designed to be used in conjunction with an appropriate size rigid esophagascope.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ or Over-The-Counter Use _

(Per 21 CFR 801.1 09)

(Divisio
I
odominal, ENT,/
vices
510(K) Number
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number K990035