(62 days)
Not Found
Not Found
No
The summary provides no indication of AI/ML technology; it describes a physical medical device (a nasal tube).
No
The device is used for "decompression and simultaneous internal feeding," which are supportive care functions rather than therapeutic interventions aimed at treating a disease or condition.
No
Explanation: The device is described as "used for decompression and simultaneous internal feeding," which indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly identifies it as a "Nasal Tube," which is a physical hardware device. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Used for decompression and simultaneous internal feeding." This describes a therapeutic and supportive function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: "Moss Tubes, Inc. Nasal Tube - Mark IV" describes a physical device inserted into the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
Therefore, the information strongly indicates that this device is a medical device used for patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Used for decompression and simultaneous internal feeding.
Product codes (comma separated list FDA assigned to the subject device)
78 BSS
Device Description
Not Found
Mentions image processing
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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.
Not Found
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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 1999
Moss Tubes, Inc. c/o Mr. Harry Schlakman Consultant to the Medical Device and Pharmaceutical Industries 304 Verona Avenue Elizabeth, NJ 07208
Re: K984629
Moss Tubes, Inc. Nasal Tube -- Mark IV Dated: December 22, 1998 -Received: December 30, 1998 Regulatory Class: II 21 CFR 876.5980/Procode: 78 BSS
Dear Mr. Schlakman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have We have reviewed your ooking notify notications for use stated in the enclosure) to legally marked predicate devices marketed in interstate commerce pror to May 28, 1976, the enactment date of the mankeled predicate de not manded beliments of the been reclassified in accordance with the provisions of the sames been Medical Device Aniendhients, or to devices that have boon receive, subject to the general controls of coline r coelar rood, Drag, and Oountolo not (Nor) 100) 1000 requirements for annual regulrements for annual registration, listing of proviolo of the Fite Frie general ce, 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 n your action is than additional controls. Existing major regulations affecting your device can be found in the Code of De Subject o Succraditional obtirolo: Extrang Major Hajaritaliy equivalent determination assumes onnliance with r carran Regulations, This a r, - and otice requirements, as set forth in the Quality System Regulation (QS) for the Outlier. Good Manadatanny (11 CFR Part 820) and that, through periodic QS inspections, the Food and Mouldingstration (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 rogulatory action. In addition, - Dr. may pour 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 rinding 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 if you ucolle uposic da not for your control 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,
J.J.
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
Image /page/0/Picture/16 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus symbol, with three intertwined snakes representing health and medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
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Exhibit IU
510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________
DEVICE NAME:
Moss Tubes, Inc. Nasal Tube - Mark IV
INDICATIONS FOR USE:
Used for decompression and simultaneous internal feeding.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| OR | |
| Over-The-Counter-Use | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K984629 |
|---|---|
| --------------- | --------- |
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