ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00

K082114 · Apollo Endosurgery, Inc. · KNS · Dec 19, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K082114
• Device Name: ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00
• Applicant: Apollo Endosurgery, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Dec 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Electrocautery Dilation Balloon is intended for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

Device Story

Electrocautery Dilation Balloon; endoscopic device for GI stricture dilation and electrosurgical tissue management. Physician-operated via endoscope or fluoroscopy. Device features inflatable balloon for dilation and integrated needle knife for cutting, dissecting, and cauterizing. Needle knife extension/retraction controlled via proximal handle. Used in clinical settings for endoscopic procedures. Provides mechanical dilation and electrosurgical tissue modification to improve patient outcomes in GI stricture management.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included inflation/deflation/burst, atraumatic tip, electrocautery extension/retraction, and corrosion testing.

Technological Characteristics

Endoscopic electrosurgical device. Features inflatable balloon and integrated needle knife. Materials are biocompatible and previously cleared. Manual operation via proximal handle. Energy source: external electrosurgical unit. No software or electronic components.

Indications for Use

Indicated for dilation of esophageal and gastrointestinal tract strictures and for cutting, dissecting, and cauterizing soft tissue during endoscopic electrosurgical procedures.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• Cordis Maxi LD Dilation Balloon (K993720)
• Cordis Maxi LD Dilation Balloon (K023907)
• Endo Surgery Needle Knife (K073046)

Submission Summary (Full Text)

{0}------------------------------------------------

K082114
1 of 2

#### 510(k) Summary

DEC 1 9 2008

General Information

Classification

Submitter

Trade Name

Electrocautery Dilation Balloon

Apollo Endosurgery, Inc. 7000 Bee Caves Road Suite 350 Austin, Texas 78746

Class II

Tel: [phone]

Contact

Dennis Mc Williams President & CEO

#### Intended Use

The Electrocautery Dilation Balloon is intended for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

## Predicate Devices

| K993720 | Cordis Maxi LD Dilation Balloon | Cordis |
|---------|---------------------------------|---------|
| K023907 | Cordis Maxi LD Dilation Balloon | Cordis |
| K073046 | Endo Surgery Needle Knife | Ethicon |

#### Device Description

The Electrocautery Dilation Balloon is indicated for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. Using either endoscopic or fluoroscopic means, the balloon is placed at the physician selected site. Once in place, the clinician inflates the balloon to dilate the stricture.

{1}------------------------------------------------

K082114
2 of 2

The electrocautery needle knife may be used for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The needle knife is advanced and retracted with the proximal handle.

## Materials

All materials used in the manufacture of the Electrocautery Dilation Balloon are suitable for this use and have been used in numerous previously cleared products.

### Testing

Product testing was completed and met specification. Testing includes inflation/deflation/burst, atraumatic tip, electrocautery extension/retraction, and corrosion testing.

## Summary of Substantial Equivalence

The Electrocautery Dilation Balloon is equivalent to the features of the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2008

Mr. Gregory Mathison Vice President Regulatory Affairs Apollo Endosurgery, Inc. 7000 Bee Caves Road, Suite 350 AUSTIN TX 78746

Re: K082114

Trade/Device Name: Electrocautery Dilation Balloon Regulation Number: 21CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: December 12, 2008 Received: December 17, 2008

Dear Mr. Mathison:

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 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.

{3}------------------------------------------------

#### 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 complive th 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 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.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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours.

Jorgu M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K082114
1 of 1

# Indications for Use

12114

510(k) Number (if known):

Device Name:

Electrocautery Dilation Balloon

Indications for Use:

The Electrocautery Dilation Balloon is intended for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hules Rem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 082114 510(k) Number .

Page 1 of 1