(222 days)
Not Found
No
The summary describes a simple nasogastric tube for fluid management and gas removal, with no mention of AI/ML terms, image processing, or performance studies related to algorithmic analysis.
Yes
The device is described as permitting the withdrawal or introduction of fluids into or from the stomach, which is a therapeutic action aimed at managing patient health.
No
Explanation: The device is used for fluid management (withdrawal/introduction) and gas removal from the stomach, which are therapeutic or management functions, not diagnostic ones.
No
The device description clearly states it is a tube inserted through the nostril, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "permit withdrawal, introduction of fluids into the stomach or removal of stomach gas via a tube inserted through the nostril." This describes a procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device description confirms its function as a tube inserted into the stomach for fluid management and gas removal. This is a medical device used for treatment or diagnosis in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
To permit withdrawal or introduction of fluids into the stomach via a tube placed through the nostril.
To permit withdrawal, introduction of fluids into the stomach or removal of stomach gas via a tube inserted through the nostril.
Product codes (comma separated list FDA assigned to the subject device)
78 FEG
Device Description
The Knott NG tube is designed to permit withdrawal or introduction of fluids through a tube which is inserted through the nostril and into the stomach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach
Indicated Patient Age Range
Adults > 100 lbs.
Intended User / Care Setting
Hospital, Operating Room (OR), nursing homes, ICU and where nasogastric tubes are required.
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.
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/0 description: The image contains two numbers, 100 and 135, arranged horizontally. The number 100 is positioned to the left of the number 135. The numbers are presented in a simple, unadorned manner against a plain background. The image is minimalist in nature, focusing solely on the numerical values.
す。 042
Michael M. Knott, M.D. 355 Pine Rose Court Tahoe City, CA 96145
| Non-Confidential Summary of Safety and Effectiveness
page 1 of 2
| November 19, 1997 | NOV | 19 1997 | |
|---|---|---|---|
| Michael M. Knott, M.D. | Tel - 916-583-9371 | ||
| 355 Pine Rose Court | |||
| Tahoe City, CA 96145 | |||
| Official Contact: | Michael M. Knott, M.D. | ||
| Proprietary or Trade Name: | Knott nasogastric tube | ||
| Common/Usual Name: | Nasogastric tube | ||
| Classification Name: | Nasogastric | ||
| Predicate Devices: | Sherwood - Salem Sump Tube - K810156 |
Device Description:
The Knott NG tube is designed to permit withdrawal or introduction of fluids through a tube which is inserted through the nostril and into the stomach.
| Indicated Use -- | To permit withdrawal or introduction of fluids into the stomach via
a tube placed through the nostril. |
|-----------------------|-----------------------------------------------------------------------------------------------------------|
| Environment of Use -- | Hospital, Operating Room (OR), nursing homes, ICU and where
nasogastric tubes are required. |
| Patient population -- | Adults > 100 lbs. |
1
Non-Confidential Summary of Safety and Effectiveness (continued) page 2 of 2 November 19, 1997
| Comparison to Predicate Devices: | ||
|---|---|---|
| Attribute | Knott | |
| NG Tube | Sherwood Salem | |
| Sump Tube | ||
| K810156 | ||
| Design | ||
| Provided in various diameters | Yes | Yes |
| Double lumen tube | Yes | Yes |
| One lumen for suction or fluids / one for venting | Yes | Yes |
| Connects to various vacuum sources | Yes | Yes |
| Tip has various holes leading to each lumen | Yes | Yes |
| May be packaged with reflux valve | Yes | Yes |
| Tubing has marking for assisting clinician | ||
| Pre-formed tip to help with insertion and advancement | Yes | Yes |
| Materials | ||
| Made of PVC | Yes | Yes |
| Packaging | ||
| Provided sterile | Yes | Yes |
| Performance Standards/Specification | ||
| None applicable under Section 514 | Yes | Yes |
Differences between Other Legally Marketed Predicate Devices
The only difference in the intended device and the predicate device is the pre-formed curve and appropriate markings on the tube to assist the clinician when to rotate the tube while inserting/advancing the tube. This difference is not viewed to be significant when addressing patient safety and effectiveness issues.
2
Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV I 9
Michael M. Knott, M.D. c/o Paul E. Dryden, President ProMedic, Inc. 6329 W. Waterview Court McCordsville, Indiana 46055 Re: K971354
Knott Nasogastric Tube Dated: August 18, 1997 Received: August 22, 1997 Regulatory class: II 21 CFR §876.5980/Product code: 78 FEG
Dear Dr. Knott:
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 requirement, 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 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 (2) 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/dsmamain.html".
Sincerely yours.
W. Liao Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.
510(k) Number: 《♀♀﹛3≤¶ -------------------------------------------------------------------------------------------------------------------------------------------------------(To be assigned)
Device Name: Knott Nasogastric Tube
Intended Use :
To permit withdrawal, introduction of fluids into the stomach or removal of stomach gas via a tube inserted through the nostril.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Rathbun/
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number 1971354
or
Prescription Use (Per CFR 801.109)
Over-the-counter use
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