(237 days)
No
The description focuses on the mechanical and material properties of a reusable overtube and bougie, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an overtube used to facilitate endoscopic procedures by providing a channel for the delivery and removal of endoscopic devices. Its function is to assist in the procedure, not to directly treat a disease or condition.
No
The device description indicates it is an overtube and introducer bougie used to facilitate delivery and removal of endoscopic devices, not to diagnose a medical condition.
No
The device description clearly describes a physical medical device (an overtube and bougie) made of materials like Tecoflex and stainless steel, intended for physical insertion into the body. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing a channel for the delivery and removal of endoscopic devices during procedures involving multiple endoscopic intubations. This is a procedural aid, not a diagnostic test performed on biological samples.
- Device Description: The device is a physical tube and bougie used to facilitate endoscopic procedures. It does not involve the analysis of biological specimens to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no indication of measuring biomarkers, detecting pathogens, or performing any other diagnostic function.
The device is a medical device used in a clinical setting to assist with a medical procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BaroSense Endogastric Tube (EGT) is indicated for use with an endoscope where multiple endoscopic intubations are anticipated.
Product codes
FED
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth to the stomach
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals or surgery centers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
K120126
510(k) Summary
SEP 10 2012
BaroSense Endogastric Tube (EGT)
BAROSENSE
General Information
| Criteria | Information |
|---|---|
| Trade Name | BaroSense Endogastric Tube and Introducer |
| Bougie | |
| Product Name | Endogastric Tube (EGT) and Introducer Bougie |
| Catalog/Model Number | Model Number: BET-01 (overtube) |
| BIB-01'(bougie) | |
| Common Name | Overtube |
| Classification | 21 CFR 876.1500- Endoscope and Accessories; |
| Class II; Product code: FED | |
| 510(k) Owner | BaroSense, Inc. |
| 250 Chesapeake Drive | |
| Redwood City CA 94063 | |
| Registration Number | 3008849950 |
| Contact Person | Sheila Stevens, PhD |
| Director Clinical and Regulatory Affairs | |
| BaroSense, Inc. | |
| sstevens@barosense.com | |
| 650-362-6016 (phone) | |
| 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
1
Predicate Devices
| Manufacturer | Predicate device | 510(k) |
|---|---|---|
| BaroSense, Inc. | ||
| 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.
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 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
3
Page 2 -
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 (800) 638-2041 or (301) 796-7100 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
4
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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