(51 days)
Not Found
Not Found
No
The summary describes a physical device (tube holder) and contains no mention of AI, ML, image processing, or data analysis typically associated with AI/ML medical devices.
No
The device is described as a holder for nasoenteric and nasogastric tubes, which are used for feeding or suction. The holder itself does not provide therapy but rather secures tubes that may be part of a therapeutic process.
No
The device is described as a "NasoGastric Tube Holder" that "securely holds nasoenteric and nasogastric tubes in the nares." This indicates a function related to securing or holding medical devices, not diagnosing a condition.
No
The device description and intended use clearly describe a physical tube holder, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "securely hold nasoenteric and nasogastric tubes in the nares." This is a physical support function for medical tubes inserted into the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or other chemical processes
- Performing tests outside of the body (in vitro)
The device is a physical medical device designed to secure tubes within the body (in vivo).
N/A
Intended Use / Indications for Use
The new Dale NasoGastric Tube Holder securely holds nasoenteric and nasogastric tubes in the nares.
Product codes
78 KNT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
nares
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)
Not Found
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
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/0/Picture/15 description: The image shows a circular logo for the Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged around the upper portion of the circle.
FEB 1 0 2000
Ms. Sharon M. Steeves Product Development Manager Dale® Medical Products, Inc. 7 Cross Street P.O. Box 1556 Plainville, MA 02762-0556
Re: K994300
NasoGastric Tube Holder, Model 160 Dated: December 20, 1999 Received: December 21, 1999 Regulatory Class: II 21 CFR §876.5980/Procode: 78 KNT
Dear Ms. Steeves:
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
1
Dale Medical Products, Inc.
7 CROSS STREET, P.O IKOX 1556, PLAINVILLE, MA 02767-0556 USA
8U0-343-3980 INT'L 508-695-9316 fAX 508-695-6587 WFR SIII www.dalemed.com
DALE® NASOGASTRIC HOLDER INDICATIONS FOR USE
The new Dale NasoGastric Tube Holder securely holds nasoenteric and nasogastric tubes in the nares.
David h. Sessor
(Division Sit ~ 197) Division : - - luctive, Abdominal, ENT, and Radica. Devi 994300 510(k) Number .
Prescription Use
(Pe FR 801.109)