(222 days)
To permit withdrawal, introduction of fluids into the stomach or removal of stomach gas via a tube inserted through the nostril.
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.
The provided document is a 510(k) premarket notification for the "Knott Nasogastric Tube," seeking clearance based on substantial equivalence to a predicate device. It is not a study reporting device performance against acceptance criteria in the manner typically associated with clinical trials or diagnostic algorithm evaluations.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication, and comparative effectiveness (MRMC) or standalone studies cannot be extracted from this document because such studies were not conducted or reported for this type of device submission.
This document focuses on demonstrating substantial equivalence in design, materials, and intended use as per FDA 510(k) requirements, not on presenting performance data from a clinical study with predefined acceptance criteria.
However, I can extract the following relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" for performance in a quantitative sense as would be found in a clinical trial evaluating a novel diagnostic or therapeutic device. Instead, it compares the attributes of the proposed device to a predicate device to establish substantial equivalence.
| Attribute | Acceptance Criteria (based on predicate device) | Reported Device Performance (Knott NG Tube) |
|---|---|---|
| Provided in various diameters | Yes (like predicate) | Yes |
| Double lumen tube | Yes (like predicate) | Yes |
| One lumen for suction or fluids / one for venting | Yes (like predicate) | Yes |
| Connects to various vacuum sources | Yes (like predicate) | Yes |
| Tip has various holes leading to each lumen | Yes (like predicate) | Yes |
| May be packaged with reflux valve | Yes (like predicate) | Yes |
| Tubing has marking for assisting clinician | Yes (like predicate) | Yes |
| Pre-formed tip to help with insertion and advancement | Yes (like predicate) | Yes |
| Made of PVC | Yes (like predicate) | Yes |
| Provided sterile | Yes (like predicate) | Yes |
| Performance Standards/Specification applicable under Section 514 | None applicable (like predicate) | None applicable |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) premarket notification for a medical device (nasogastric tube), not a study involving a test set of data or human subjects for performance evaluation in the described manner. The submission relies on a comparison to a legally marketed predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "test set" or "ground truth" in this context as it's not a diagnostic or AI-based device performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "proof" of meeting criteria for this device is based on demonstrating substantial equivalence to a legally marketed predicate device through comparison of attributes (design, materials, intended use), rather than clinical performance against a ground truth.
8. The sample size for the training set
Not applicable. There is no training set mentioned or implied for this device's submission.
9. How the ground truth for the training set was established
Not applicable.
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す。 042
Michael M. Knott, M.D. 355 Pine Rose Court Tahoe City, CA 96145
| Non-Confidential Summary of Safety and Effectivenesspage 1 of 2November 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 viaa tube placed through the nostril. |
|---|---|
| Environment of Use -- | Hospital, Operating Room (OR), nursing homes, ICU and wherenasogastric tubes are required. |
| Patient population -- | Adults > 100 lbs. |
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Non-Confidential Summary of Safety and Effectiveness (continued) page 2 of 2 November 19, 1997
| Comparison to Predicate Devices: | ||
|---|---|---|
| Attribute | KnottNG Tube | Sherwood SalemSump TubeK810156 |
| 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 clinicianPre-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.
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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
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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
Page 10 of 23
§ 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.