BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE

K120126 · Barosense, Inc. · FED · Sep 10, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K120126
• Device Name: BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
• Applicant: Barosense, Inc.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Sep 10, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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

Device Story

Reusable overtube and flexible introducer bougie used in hospitals/surgery centers to provide a channel for endoscopic device delivery/removal from mouth to stomach. Physician-operated. Introducer bougie features tapered tip and internal lumen for 5 mm endoscope. Modified device includes proximal handle feature to grip/seal to bougie or other endoscopic devices, preventing relative motion. Reusable overtube replaces single-patient-use predicate. Benefits include facilitated multiple intubations/exchanges during endoscopic procedures.

Clinical Evidence

No clinical data. Safety and effectiveness established through bench and animal testing. All patient-contacting components tested for biocompatibility per ISO 10993.

Technological Characteristics

Overtube material: Tecoflex with embedded stainless steel reinforcement coil. Introducer bougie: flexible with tapered tip and internal lumen. Biocompatibility: ISO 10993 compliant. Connectivity: None. Energy source: None (mechanical). Sterilization: Supplied non-sterile.

Indications for Use

Indicated for use with an endoscope in patients where multiple endoscopic intubations or 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

• Endogastric Tube (EGT) (K082589)

Submission Summary (Full Text)

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# K120126

# 510(k) Summary

SEP 10 2012

### BaroSense Endogastric Tube (EGT)

BAROSENSE

#### General Information

| Criteria | Information |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | BaroSense Endogastric Tube and Introducer<br>Bougie |
| Product Name | Endogastric Tube (EGT) and Introducer Bougie |
| Catalog/Model Number | Model Number: BET-01 (overtube)<br>BIB-01'(bougie) |
| Common Name | Overtube |
| Classification | 21 CFR 876.1500- Endoscope and Accessories;<br>Class II; Product code: FED |
| 510(k) Owner | BaroSense, Inc.<br>250 Chesapeake Drive<br>Redwood City CA 94063 |
| Registration Number | 3008849950 |
| Contact Person | Sheila Stevens, PhD<br>Director Clinical and Regulatory Affairs<br>BaroSense, Inc.<br>[e-mail]<br>650-362-6016 (phone)<br>650-362-0070 (fax) |

#### Summary of Substantial Equivalence

The BaroSense, Inc., Endogastric Tube (EGT) and Introducer Bougie (Model BET-01 and BIB-01) are substantially equivalent to the BaroSense Endogastric Tube (EGT) Model F0034.

Date: March 13, 2012

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#### Predicate Devices

| Manufacturer | Predicate device | 510(k) |
|-------------------------------------|------------------------|---------|
| BaroSense, Inc.<br>Redwood City, CA | Endogastric Tube (EGT) | K082589 |

#### Device Description

The EGT is a reusable 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. A flexible Introducer Bougie has a tapered tip to assist in introduction of the EGT through the mouth and esophagus. The bougie has an internal lumen to accommodate a 5 mm endoscope.

The EGT and Introducer Bougie are supplied non-sterile.

The predicate device has identical technological characteristics. However, the predicate EGT is provided as a single-patient-use, disposable unit, with an internal bougie introducer included in the package. The modified device is provided as a reusable overtube and single-use bougie. The predicate device working tube is a PVC tube with an embedded stainless steel reinforcement coil, whereas the modified device is a Tecoflex tube with an embedded stainless steel reinforcement coil. The proximal handle of the modified device has an added feature to allow the endogastric tube to grip and seal to Introducer Bougie or other endoscopic devices. This gripping action prevents relative motion between the overtube and the other devices, e.g., the Introducer Bougie.

#### Indications for Use

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

#### Bench/Animal Testing

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

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#### 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 stylized eagle with three lines forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Sheila Stevens, Ph.D. Director, Clinical and Regulatory Affairs BaroSense, Inc. 250 Chesapeake Drive REDWOOD CITY CA 94063

SEP
10
2012

Re: K120126

Trade/Device Name: BaroSense Endogastric Tube (EGT) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: August 13, 2012 Received: August 14, 2012

Dear Dr. Stevens:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see 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 Federal statutes and regulations administered by other Federal agencies. You must or ury reater others the requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements.as set do rtoo thator adverses or (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you uchte spocific darilos to: your conters offices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Comer to: Donetto and "Misbranding by reference to premarket notification" (21CFR Part note the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the I ou may oount other general meetings and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher, Ph.D.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indications for Use

510(k) Number (if known): K120126

Device Name: BaroSense Endogastric Tube (EGT)

Indications for Use: The BaroSense Endogastric Tube (EGT) 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)

currence of ORH)Office of Device Evaluation (ODE)

sion Sidn-Off ion of Reproductive, ological Devic 510(k) Number

510(k) K120126 - Additional Information #1 BAROSENSE, INC.

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