BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034

K082589 · Barosense, Inc. · FED · May 22, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K082589
• Device Name: BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034
• Applicant: Barosense, Inc.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: May 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The BaroSense Endogastric Tube is indicated for use with an endoscope where multiple endoscopic intubations are anticipated.

Device Story

BaroSense EGT is a single-use, disposable overtube; used in hospitals or surgery centers; provides a channel for delivery and removal of endoscopic devices from mouth to stomach. Device includes a removable, flexible introducer with a tapered tip to assist insertion through mouth and esophagus. Operated by clinicians during endoscopic procedures. Facilitates multiple intubations or instrument exchanges; protects esophagus; simplifies tool access. Benefits patient by reducing trauma associated with repeated endoscope insertion.

Clinical Evidence

Bench testing only. Biocompatibility of all patient-contacting components verified per ISO 10993. Safety and effectiveness established through bench testing with acceptable results.

Technological Characteristics

Single-use, disposable overtube. Includes flexible introducer with tapered tip. Materials tested for biocompatibility per ISO 10993. Non-sterile supply. Mechanical device; no energy source or software.

Indications for Use

Indicated for use with an endoscope in patients where multiple endoscopic intubations or endoscopic instrument/tool exchanges are anticipated.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Guardus™ Disposable Overtube (K040836)
• Overtube (K002018)
• Endoscopic Overtube (K973500)

Submission Summary (Full Text)

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

MAY 22 2009

# 510(k) Summary of Safety and Effectiveness

## BaroSense Endogastric Tube

Image /page/0/Picture/3 description: The image shows the logo for Barosense Inc. The logo features a stylized figure with arms raised, next to the word "BAROSENSE" in all caps. Below "BAROSENSE" is the abbreviation "Inc."

## General Information

| Criteria | Information |
|----------------------|--------------------------------------------------------------------------------------------------------------------------|
| Trade Name | BaroSense Endogastric Tube<br>(Note: a trademark name is still being finalized and<br>may be added to that listed above) |
| Product Name | Endogastric Tube (EGT) |
| Catalog/Model Number | Model # F0034 |
| Common Name | Overtube |
| Classification | 21 CFR 876.1500- Endoscope and Accessories;<br>Class II; Product code: KOG |
| 510(k) Owner | BaroSense, Inc.<br>3698-C Haven Ave.<br>Redwood City CA 94063 |
| Contact Person | Daniel J. Balbierz, Chief Operating Officer<br>BaroSense, Inc.<br>[e-mail] |
| | 650-362-6000 (phone) 650-362-0700 (fax) |

## Summary of Substantial Equivalence

The BaroSense Inc., Endogastric Tube does not raise any new safety or effectiveness issues and is substantially equivalent to legally marketed overtubes that are in commercial distribution, and has been determined to be substantially equivalent to devices in commercial distribution, prior to May 28, 1976.

Date: March 23, 2009

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

K082 989

### Substantially Equivalent Devices

| Manufacturer | Substantially equivalent device | 510(k) |
|--------------------------------|---------------------------------|---------|
| US Endoscopy<br>Mentor, OH | Guardus™ Disposable Overtube | K040836 |
| NDO Surgical<br>Mansfield, MA | Overtube | K002018 |
| CR Bard, Inc.<br>Billerica, MA | Endoscopic Overtube | K973500 |

### Device Description

The BaroSense EGT is a single use, disposable, overtube used in hospitals or surgery centers to provide a channel for the delivery and removal of endoscopic devices from the mouth to the stomach. It is intended for use when multiple endoscopic intubations, or endoscopic instrument/tool exchanges, are anticipated.

The EGT is supplied non-sterile and is provided with a removable, flexible introducer with a tapered tip that assists in introduction of the EGT through the mouth and esophagus.

#### Indications for Use

The BaroSense EGT is indicated for use with an endoscope where multiple endoscopic intubations are anticipated.

### Bench Testing

All patient contacting components of the EGT are composed of materials of known biocompatibility tested to the requirements of ISO 10993. The safety and effectiveness of the device was further established through a series of bench tests. All testing yielded acceptable results.

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge to form the shape of a bird.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

22 2009 MAY

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel J. Balbierz President and CEO BaroSense, Inc. 3698-C Haven Avenue REDWOOD CITY CA 94063

Re: K082589

Trade/Device Name: · BaroSense Endogastric Tube (EGT), model F0034 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: March 30, 2009 Received: April 1, 2009

Dear Mr. Balbierz:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other

(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology). (Radiology)

[phone] [phone] [phone] [phone]

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Janie M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): K0802589 KO82589

Device Name: Endogastric Tube (EGT)

Indications for Use: The BaroSense Endogastric Tube is indicated for use with an endoscope where multiple endoscopic intubations are anticipated.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR ·

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helens

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

510(k) Number_

510(k) K082589 - Additional Information #2 BAROSENSE, INC.

page 3 of 21 CONFIDENTIAL

Page 1 of 1