(57 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI or ML.
No.
The device description and intended use indicate it is an ancillary surgical tool for positioning, sizing, and performing leak tests during gastric and bariatric procedures, rather than directly treating a disease or condition.
Yes
The device is used to "test for leaks," which is a diagnostic function to determine the presence of a leak.
No
The device description clearly states it is a "40FR flexible, non-sterile, single-use, dual lumen gastric tube" with physical components like lumens, a Sail feature, integrated LED guidelights, and distal holes. This indicates a hardware-based medical device, not software-only.
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. They are used to provide information for diagnosis, monitoring, or screening.
- GastriSail™ Function: The GastriSail™ is a device used during surgical procedures within the body (in vivo). Its functions are mechanical and visual: suction, decompression, expansion, drainage, leak testing, delineation, and sizing. It does not analyze samples taken from the body.
The description clearly indicates it's a surgical tool used directly within the patient's esophagus and stomach during a procedure.
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
KNT
Device Description
The GastriSail™ Gastric Positioning System is a 40FR 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
gastric, stomach, esophagus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
anesthesiologist
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)
Non Clinical testing that supports the intended use of this device includes:
- . Visual Inspection
- . Dimensional Measurement
- Vacuum Pressure Evaluation
- I Tensile Test Evaluation
- I Battery Test
In vivo testing that supports the intended use of this device includes:
- . Evaluation of esophageal insertion test in porcine
Only Non Clinical Testing was performed for the proposed changes therefore, clinical testing was not performed or relied on for a determination of substantial equivalence.
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
§ 876.5980 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2016
Covidien LLC Rebecca Magnanimo Regulatory Affairs Product Specialist 60 Middletown Ave. North Haven, CT 06473
Re: K160654
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: April 7, 2016 Received: April 13, 2016
Dear Rebecca Magnanimo:
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.
1
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.
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K160654
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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Summary
| SUBMITTER: | Covidien Ilc
60 Middletown Avenue
North Haven, CT 06473 USA |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Rebecca Magnanimo
Regulatory Affairs Product Specialist
Covidien Ilc
Phone: (203) 492-6479
Fax: (203) 492-5029
e-mail: Rebecca.magnanimo@covidien.com |
| DATE PREPARED: | 02/22/16 |
| PRODUCT CODE: | KNT |
| REGULATION NUMBER: | 21CFR 876.5980 |
| TRADE/PROPRIETARY NAME: | GastriSail™ Gastric Positioning System |
| COMMON/USUAL NAME: | Gastric Positioning System |
| CLASSIFICATION NAME: | Tubes, Gastrointestinal (and Accessories) |
| PREDICATE DEVICES: | GastriSail™ Gastric Positioning System (K143088) |
| DEVICE DESCRIPTION: | The GastriSail™ Gastric Positioning System is a 40FR 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. |
| 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. |
4
SUMMARY COMPARING THE TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES:
Modifications to design of the current GastriSail™ Gastric Positioning System (K143088) has created a new product to be launched as the proposed GastriSail™ Gastric Positioning System 40 Fr/Ch (13.3mm).
The changes include a change in the size of diameter of the lumen flexible tubing from a 36 Fr/Ch (12.0mm) (predicate) to a 40 Fr/CH (13.3mm)(proposed) size. Increasing tube diameter by (1.3mm).
Additionally, there will also be a material change to the previously cleared 36 Fr/Ch GastriSail™ Gastric Positioning System (K143088). The tip material for the 36Fr/Ch and 40Fr/Ch will be changing from a polycarbonate to a Silastic Silicone material.
The proposed GastriSail™ Gastric Positioning System 40 Fr/Ch (13.3mm) was evaluated for the following:
- . Biocompatibility testing was conducted to evaluate proposed tip material change from polycarbonate to silastic silicone in accordance with ISO 10993-1:2009.
- I Stability testing was conducted to evaluate proposed tip material change from polycarbonate to silastic silicone.
- . Performance studies (nonclinical testing) was conducted to demonstrate that the proposed device, is substantially equivalent to the predicate device.
Non Clinical testing that supports the intended use of this device includes:
- . Visual Inspection
- . Dimensional Measurement
- Vacuum Pressure Evaluation
- I Tensile Test Evaluation
- I Battery Test
In vivo testing that supports the intended use of this device includes:
- . Evaluation of esophageal insertion test in porcine
GastriSail™ Gastric Positioning System is sold nonsterile therefore sterility is not required. Only Non Clinical Testing was performed for the proposed changes therefore, clinical testing was not performed or relied on for a determination of substantial equivalence.
NONCLINICAL TESTING
IN VIVO TESTING
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| CHARACTERISTICS | Proposed
GastriSail™ Gastric
Positioning Systm | K143088
GastriSail™ Gastric
Positioning System |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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. |
| Length of tube | 132 cm (total) | 132 cm (total) |
| Tubing | Multi lumen with rounded,
closed distal end | Multi lumen with rounded,
closed distal end |
| Size | 40 FR | 36 Fr |
| Sterility | Clean, Non Sterile, single-
patient use | Clean, Non Sterile, single-
patient use |
| Suction fixation | Yes | Yes |
| Decompression
capability | Yes | Yes |
| Sail feature | Yes | Yes |
| LED Guide lights | Yes | Yes |
| Disposable | Yes | Yes |
| Tip Material | Silastic Silicone | Polycarbonate |
CONCLUSION:
The results of testing demonstrate that the modified GastriSail™ Gastric Positioning System 40 Fr/Ch (13.3mm) is substantially equivalent to the legally marketed GastriSail™ Gastric Positioning System (K143088).