(150 days)
No
The description focuses on electromagnetic sensing and signal processing to determine tube tip location and direction, with no mention of AI/ML algorithms for interpretation or prediction.
No.
The device is intended to aid in the placement of an enteral feeding tube by providing real-time location and direction information, not to treat or diagnose a disease or condition. Its function is to assist in a medical procedure, not to provide therapy.
No
The device is intended to assist in the placement of enteral feeding tubes by providing real-time location and direction information of the tube tip. It does not diagnose a disease, condition, or state of health. Its primary function is navigational assistance, with final tube position confirmation relying on standard diagnostic procedures (x-ray, aspiration, auscultation).
No
The device description explicitly states the system includes a sensor device permanently mounted inside a sensor stylet (MAPCath) and an electronic transmitter / receiver instrument (NAVIGATØR), indicating significant hardware components beyond just software.
Based on the provided information, the BioNavigation System for Placement of Enteral Feeding Tubes is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this system is used to track the position of a tube within a patient's body during a procedure. It does not analyze any biological samples or specimens.
- The system provides real-time information about the physical location and direction of the tube tip. This is a navigational and procedural aid, not a diagnostic test performed on a sample.
The system's function is to assist a clinician in a medical procedure by providing positional information, which falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
The BioNavigation System for Placement of Enteral Feeding Tubes is intended to be assure to and in action information of the tube tip as it moves through a patient during the tube placement procedure.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
The BioNavigation System for Placement of Enteral Feeding Tubes is designed to aid in the placement of an enteral feeding tube by providing a clinician with real-time information as to the location and direction of the tube tip during the placement procedure. Commonly used anatomical external markers used in auscultation procedures allow the clinician to approximate the internal position of the tube tip. Final tube position is confirmed using standard institutional procedures (x-ray, aspiration, or auscultation).
The system includes a sensor device permanently mounted inside a sensor stylet (MAPCath) and an electronic transmitter / receiver instrument (NAVIGATØR) that emits low level electromagnetic signals that are sensed by the sensor device in the tip of the stylet. Prior to initiation of the enteral feeding tube insertion procedure, the MAPCath sensor stylet is positioned inside the lumen of the enteral tube adjacent to the standard stylet supplied with the tube. The sensor in the tip of the stylet is positioned near the tip of the tube and the stylet is locked in place.
As the instrument is moved in the proximity of the sensor the instrument measures the change in response of the sensor and determines the relationship between the position of the sensor and the position of the instrument. The instrument provides an audible and visual display indicating when the NAVIGATØR instrument is positioned directly over the tube tip and also provides an indication of the direction the tube tip is pointing.
In use, the tube is placed into the stomach following standard institutional procedures. To position the tube in the small bowel, the tube is either allowed to passively advance towards the pyloric sphincter due to normal digestive action or is manually advanced following individual institutional techniques. The tube tip position can be monitored using the instrument.
When the tube tip is seen to pass across the patient's midline it is exiting the stomach through the pyloric sphincter and entering the duodenum. As the tube advances and enters the duodenum, the tube tip will be seen to change direction and move towards the patient's feet. By continuing to allow the tube to advance, the tube tip will exit the duodenum and enter the small bowel. At this point the tube tip will move in a direction back toward the midline. Once it is determined that the tube tip is in the small bowel, the MAPCath sensor stylet can be withdrawn. By withdrawing the MAPCath in a series of steps (e.g., withdrawn 10 cm at a time), the position and direction of the tube path can be reconfirmed using the NAVIGATØR instrument. The position and direction of the tube can be mapped on the anatomical chart supplied on the instructions for use to record the tube position. When the MAPCath is fully withdrawn it is discarded.
Once the tube has been placed, the tube tip position is confirmed using standard institutional procedures (e.g., x-ray, aspiration, or auscultation).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
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.
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3/1/99
Navion Biomedical Corp. Premarket Notification Information
I. GENERAL INFORMATION
- Applicant: Navion Biomedical Corp. 312 Tosca Drive Stoughton, MA 02072 Establishment Registration # 1222311
- Donald A. Kay Contact: Telephone: (781) 341-8058 FAX: (781) 341-8077 e-mail: navionbio@aol.com
II. DEVICE NAME
- BioNavigation System for Placement of Enteral 1) Trade Name: Feeding Tubes Enteral Tube Location System 2) Common Name: 3) Classification Name: unclassified
III. DEVICE CLASSIFICATION
Unclassified
IV. PURPOSE OF SUBMISSION
This submission describes a new device system for which a substantial equivalent determination is requested. The system includes a disposable MAPCath sensor stylet, which when inserted inside the lumen of an enteral feeding tube and used in conjunction with the Navion NAVIGATØR electronic instrument, allows the clinician to track the position and direction of the enteral feeding tube as it is moved inside of a patient during the tube placement procedure.
V. PERFORMANCE STANDARDS
The FDA has promulgated no performance standards for this device.
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VI. APPLICATION BACKGROUND
Enteral feeding tubes are used in patients that can not consume an adequate diet orally and due to surgery, trauma or underlying disease can not be fed via the gastric system (stomach). To deliver nutritional support to these patients modified food is passed via an enteral feeding tube to the small bowel. Enteral tubes are initially placed in a similar manner to gastric feeding tubes by passing the tube through the patient's nasal passages into the esophagus and on into the stomach. Subsequently, enteral tubes are advanced out of the stomach, through the pyloric sphincter and into the duodenum and small bowel. In many instances, the tubes are allowed to naturally pass out of the stomach with normal digestive action. This can take 24 hours or longer. In some institutions special manipulations are performed to try to get the tube to move more rapidly. These can include the use of prokinetic drugs to stimulate the stomach to pass the tube more quickly.
Because feeding of the patient can not be initiated until the tube tip is in the duodenum or small bowel, frequent checks must be made on the tube tip location to determine the progress of the tube as it moves out of the stomach. Tip location is normally approximated by aspiration, auscultation or x-ray depending upon individual institution practice.
In aspiration, fluid is withdrawn from the tube and the pH and color of the fluid is determined. An acidic pH indicates the tube tip is still in the stomach / a pH greater than 6 and yellow color fluid indicates the tube tip is in the duodenum or small bowel.
In auscultation air is injected into the lumen of the tube and by listening for gurgling sounds emitted from the tube tip with a stethoscope an approximation of the tip location is made. Common anatomical markers are used to correlate the external position found with the stethoscope to the internal position of the tube tip. Generally, when the tube tip is found to have crossed the patient's midline (as the stomach is normally located on the patient's left side, the tip will be seen to pass from the left side to the right side) it is felt that the tube is exiting the stomach and entering the pyloric sphincter and duodenum. Both aspiration and auscultation are time consuming for the medical staff. The aspiration procedure may expose staff to potentially infectious fluids.
When x-ray is used to monitor the progress of the tube tip, the patient is usually subjected to multiple x-ray exposures. Typically, a portable x-ray unit must be repeatedly brought to the patient or the patient must be repeatedly brought to radiology. Because these procedures are expensive (x-rays) and time
2
consuming the number of times the tube position is checked may be limited. This can result in a delay of nutritional support for the patient.
VII. PREDICATE DEVICE
Flexiflo Tube Placement Verifier (K922216), distributed by Ross Laboratories, Division of Abbott Laboratories, 625 Cleveland Ave., Columbus, OH 43215.
The Flexiflo Tube Placement Verifier is designed to aid in the placement of an enteral feeding tube by providing a clinician with real-time information as to the location of the tube tip during the placement procedure. Commonly used anatomical external markers used in auscultation procedures allow the clinician to approximate the internal position of the tube tip. Final tube position is confirmed using standard institutional procedures (x-ray, aspiration, or auscultation).
The system includes a sensor device permanently mounted inside the tip of a feeding tube and an electronic transmitter / receiver instrument that emits low level electromagnetic signals that are sensed by the sensor device in the tube tip. As the instrument is moved in the proximity of the sensor the instrument measures the change in response of the sensor and determines the relationship between the position of the sensor and the position of the instrument . The instrument provides a visual display indicating the direction the instrument should be moved to locate the tip of the tube and a second display to indicate when the instrument is directly over the tube tip.
In use, the tube is placed into the stomach following standard institutional procedures. To position the tube in the small bowel, the tube is either allowed to passively advance towards the pyloric sphincter due to normal digestive action or is manually advanced following individual institutional techniques. The tube tip position can be monitored using the instrument.
When the tube tip is seen to pass across the patient's midline it is exiting the stomach through the pyloric sphincter and entering the duodenum. As the tube advances and enters the duodenum, the tube tip will be seen to change direction and move towards the patient's feet. By continuing to allow the tube to advance, the tube tip will exit the duodenum and enter the small bowel. At this point the tube tip will move in a direction back toward the midline.
Once it is determined that the tube tip is in the small bowel, the tube tip position is confirmed using standard institutional procedures (e.g., x-ray, aspiration, or auscultation).
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Navion Biomedical Corp. Premarket Notification Information
VIII. PROPOSED DEVICE
BioNavigation System for Placement of Enteral Feeding Tubes, Navion Biomedical Corp., 312 Tosca Drive, Stoughton, MA 02072.
The BioNavigation System for Placement of Enteral Feeding Tubes is designed to aid in the placement of an enteral feeding tube by providing a clinician with real-time information as to the location and direction of the tube tip during the placement procedure. Commonly used anatomical external markers used in auscultation procedures allow the clinician to approximate the internal position of the tube tip. Final tube position is confirmed using standard institutional procedures (x-ray, aspiration, or auscultation).
The system includes a sensor device permanently mounted inside a sensor stylet (MAPCath) and an electronic transmitter / receiver instrument (NAVIGATØR) that emits low level electromagnetic signals that are sensed by the sensor device in the tip of the stylet. Prior to initiation of the enteral feeding tube insertion procedure, the MAPCath sensor stylet is positioned inside the lumen of the enteral tube adjacent to the standard stylet supplied with the tube. The sensor in the tip of the stylet is positioned near the tip of the tube and the stylet is locked in place.
As the instrument is moved in the proximity of the sensor the instrument measures the change in response of the sensor and determines the relationship between the position of the sensor and the position of the instrument . The instrument provides an audible and visual display indicating when the NAVIGATØR instrument is positioned directly over the tube tip and also provides an indication of the direction the tube tip is pointing.
In use, the tube is placed into the stomach following standard institutional procedures. To position the tube in the small bowel, the tube is either allowed to passively advance towards the pyloric sphincter due to normal digestive action or is manually advanced following individual institutional techniques. The tube tip position can be monitored using the instrument.
When the tube tip is seen to pass across the patient's midline it is exiting the stomach through the pyloric sphincter and entering the duodenum. As the tube advances and enters the duodenum, the tube tip will be seen to change direction and move towards the patient's feet. By continuing to allow the tube to advance, the tube tip will exit the duodenum and enter the small bowel. At this point the tube tip will move in a direction back toward the midline. Once it is determined that the tube tip is in the small bowel, the MAPCath sensor stylet
4
can be withdrawn. By withdrawing the MAPCath in a series of steps (e.g., withdrawn 10 cm at a time), the position and direction of the tube path can be reconfirmed using the NAVIGATØR instrument. The position and direction of the tube can be mapped on the anatomical chart supplied on the instructions for use to record the tube position. When the MAPCath is fully withdrawn it is discarded.
Once the tube has been placed, the tube tip position is confirmed using standard institutional procedures (e.g., x-ray, aspiration, or auscultation).
The NAVIGATØR instrument is the same instrument that received concurrence under K940385. The MAPCath sensor stylet received concurrence under K901263 and is currently marketed to place central venous catheters.
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Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 -1000
Mr. Donald A. Kay President Navion Biomedical Corp. 312 Tosca Drive Stoughton, MA 02072
Re: K983476 BioNavigation System for Placement of Enteral Feeding Tubes Dated: January 27, 1999 Received: January 28, 1999 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT
Dear Mr. Kay:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Navion Biomedical Corp. Premarket Notification Information
IX. INDICATIONS FOR USE
The BioNavigation System for Placement of Enteral Feeding Tubes is intended the DioNavigation of enteral feeding tubes by providing realto be assure to and in action information of the tube tip as it moves through a patient during the tube placement procedure.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Over-The-Counter Use _
(Per 21 CFR 801.109)
Yinpl L. Segmen
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number .