(120 days)
Not Found
No
The description focuses on mechanical and electrical components for suction, drainage, and visual guidance, with no mention of AI or ML.
No
The device is used during gastric and bariatric surgical procedures for functions like suction, decompression, leak testing, and serving as a sizing guide, rather than providing therapy for a disease or condition.
Yes
The device is indicated to "test for leaks," which is a diagnostic function.
No
The device description clearly outlines a physical, flexible tube with lumens, a Sail feature, integrated LED guidelights, and distal holes for suction. This is a hardware device.
Based on the provided information, the GastriSail™ Gastric Positioning System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- GastriSail™ Function: The GastriSail™ is a device inserted into the body (esophagus and stomach) during surgical procedures. Its functions are mechanical and related to manipulating and managing the stomach during surgery (suction, decompression, expansion, sizing, leak testing, delineation).
- No Sample Analysis: The description does not mention the device analyzing any biological samples taken from the patient. Its purpose is to assist the surgeon directly within the body.
Therefore, the GastriSail™ falls under the category of a surgical device or instrument, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The GastriSail™ Gastric Positioning System is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
The GastriSail™ Gastric Positioning System is a 36FR flexible, non-sterile, single-use, dual lumen gastric tube designed to be inserted into the esophagus by an anesthesiologist for use in gastric and bariatric surgical procedures, such as sleeve gastrectomy.
The GastriSail™ Gastric Positioning System consists of a dual lumen flexible tube. One lumen houses the Sail feature and integrated LED guidelights, and the other lumen has rows of distal holes which, when connected to suction provides vacuum to the stomach for evacuation of stomach contents and suction fixation along the lesser curvature of the stomach. This lumen is also used to perform leak testing at the end of the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Stomach, esophagus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Anesthesiologist (for insertion); in gastric and bariatric surgical procedures.
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)
GastriSail™Non-clinical Testing:
- Dimensional analysis
- Tensile testing of adhered bonds
- Battery functional testing
- Vacuum relief testing
- Suction tubing adapter test
Comparative testing to the predicate device, Realize™ Gastric Calibration Tube
- Decompression of the stomach:
- Suction fixation and evacuation of stomach contents
- Sizing of a Gastric Sleeve
In-vivo Evaluation of esophageal insertion test in porcine
Electrical Safety Testing:
- IEC 60601-1: Ed3
- IEC 60601-1-2: Ed 4
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2015
Covidien Debbie Peacock Regulatory Product Manager 60 Middletown Ave. North Haven. CT 06473
Re: K143088
Trade/Device Name: Gastrisail Gastric Positioning System Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 9, 2015 Received: January 12, 2015
Dear Debbie Peacock,
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K143088
Device Name
GastriSail™ Gastric Positioning System
Indications for Use (Describe)
The GastriSail™ Gastric Positioning System is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Traditional 510(k) Summary
| SUBMITTER: | Covidien llc
60 Middletown Avenue
North Haven, CT 06473 USA |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Debra Peacock
Regulatory Affairs Product Manager
Covidien llc
Phone: (203) 492-6935
Fax: (203) 492-5029
e-mail: debra.peacock@covidien.com |
| DATE PREPARED: | 10/27/2014 |
| PRODUCT CODE: | KNT |
| REGULATION NUMBER: | 21CRF 876.5980 |
| REVIEW PANEL: | Gastroenterology/Urology |
| TRADE/PROPRIETARY NAME: | GastriSail™ Gastric Positioning System |
| COMMON/USUAL NAME: | Gastric Positioning System |
| CLASSIFICATION NAME: | Tubes, Gastrointestinal (and Accessories) |
| PREDICATE DEVICES: | 1). Realize™ Gastric Calibration Tube (K071764). Mfg by
Ethicon
2). ViSiGi3D™ Sleeve Gastrectomy Calibration System with
Bulb (K130483). Mfg by Boehringer Laboratories |
| DEVICE DESCRIPTION: | The GastriSail™ Gastric Positioning System is a 36FR
flexible, non-sterile, single-use, dual lumen gastric tube
designed to be inserted into the esophagus by an
anesthesiologist for use in gastric and bariatric surgical
procedures, such as sleeve gastrectomy.
The GastriSail™ Gastric Positioning System consists of a dual
lumen flexible tube. One lumen houses the Sail feature and
integrated LED guidelights, and the other lumen has rows of
distal holes which, when connected to suction provides
vacuum to the stomach for evacuation of stomach contents and
suction fixation along the lesser curvature of the stomach.
This lumen is also used to perform leak testing at the end of
the procedure. |
4
INTENDED USE
The GastriSail™ Gastric Positioning System is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.
| CHARACTERISTICS | Proposed
GastriSail™ Gastric
Positioning System | Predicate
ViSiGi 3D
(K130483) | Predicate
RealizeTMGastric
Calibration Tube
(K071764) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IFU | The GastriSail™ Gastric
Positioning System is indicated
for use in gastric and bariatric
surgical procedures for the
application of suction,
decompression and to radially
expand the stomach, to drain
gastric fluids, to test for leaks,
to provide visible and tactile
delineation of the lesser
curvature of the stomach and to
serve as a sizing guide for
gastric and bariatric
procedures, such as sleeve
gastrectomy. | The ViSiGi 3D™ is
indicated for use in gastric
and bariatric surgical
procedures for the
application of suction,
stomach decompression,
drainage of gastric fluids,
irrigation and to serve as a
sizing guide. | The Ethicon Endo-Surgery
Gastric Calibration Tube is
indicated for use in gastric
and bariatric surgical
procedures to provide visible
and tactile delineation of the
antrum of the stomach along
with the ability to
decompress the stomach,
drain and remove gastric
fluid, and size a gastric
pouch. |
| Length of tube | 132 cm (total) | 107 cm | 74.5 cm |
| Tubing | Multi lumen with rounded,
closed distal end | Single lumen with rounded,
closed distal end | Single lumen with rounded,
closed distal end |
| Size | 36 Fr | 36 and 40 Fr | 38 Fr |
| Sterility | Clean, Non Sterile, single-
patient use | Same | Same |
| Suction fixation | Yes | Yes | Yes |
| Decompression
capability | Yes | Yes | Yes |
| Sail feature | Yes | No | No |
| LED Guide lights | Yes | No | No |
| Disposable | Yes | Yes partly | Yes |
5
| MATERIALS: | Materials have been tested for Biocompatibility in accordance
with ISO 10993-1:2009 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PERFORMANCE DATA: | Design verification studies and Performance studies were
conducted as summarized below: |
| | GastriSail™Non-clinical Testing:
● Dimensional analysis
● Tensile testing of adhered bonds
● Battery functional testing
● Vacuum relief testing
● Suction tubing adapter test |
| | Comparative testing to the predicate device, Realize™ Gastric
Calibration Tube
● Decompression of the stomach:
● Suction fixation and evacuation of stomach contents
● Sizing of a Gastric Sleeve |
| | In-vivo Evaluation of esophageal insertion test in porcine
Electrical Safety Testing:
● IEC 60601-1: Ed3
● IEC 60601-1-2: Ed 4 |
| CONCLUSION: | It has been demonstrated that the proposed GastriSail™
Gastric Positioning System is substantially equivalent to the
legally-marketed Ethicon Realize™ Gastric Calibration Tube
(K071764), and to the Boehringer ViSiGi3D™ Sleeve |
Gastrectomy Calibration System with Bulb (K130483).