MOSS TUBES, INC. NASAL TUBE - MARK IV by MOSS TUBES, INC.

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Moss Tubes, Inc. Nasal Tube - Mark IV". This type of document does not typically contain detailed information about acceptance criteria or specific study results. It primarily states that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, most of the requested information cannot be extracted from the provided text. I will indicate where information is missing.

Here's what can be inferred and what is explicitly stated:

Acceptance Criteria and Device Performance

Acceptance Criteria: Not explicitly stated in the document. A 510(k) clearance is based on substantial equivalence to a predicate device, meaning the new device is as safe and effective as a device already on the market. The acceptance criteria would likely relate to demonstrating this equivalence through performance testing, material biocompatibility, and sterilization validation, but the specific metrics are not detailed here.
Reported Device Performance: Not explicitly stated. The document affirms the device's substantial equivalence to a predicate device based on its intended use (decompression and simultaneous internal feeding). No specific performance metrics (e.g., accuracy, sensitivity, specificity, flow rates, durability) are provided.

Study Details

Table of Acceptance Criteria and Reported Device Performance: This information is not present in the provided document.
Sample size used for the test set and the data provenance: Not mentioned. 510(k) submissions often include bench testing and sometimes limited clinical data, but the specifics of any test set (e.g., sample size, country of origin, retrospective/prospective) are not provided in this clearance letter.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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 a "Nasal Tube," which is a physical medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For a physical device like a nasal tube, "ground truth" might relate to physical properties, biocompatibility, or functional performance, but the specifics are not detailed.
The sample size for the training set: Not applicable and not mentioned. This is not an AI device that typically involves a "training set." Any "training" would be related to user training or manufacturing processes.
How the ground truth for the training set was established: Not applicable and not mentioned.

In summary, the provided FDA 510(k) clearance letter confirms that the Moss Tubes, Inc. Nasal Tube - Mark IV has been reviewed and found substantially equivalent to predicate devices for its stated indications for use. However, it does not contain the detailed study design, acceptance criteria, or performance data that would typically be required to answer most of your specific questions, as these details are usually part of the full 510(k) submission, not the clearance letter itself.

Summary

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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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Regulation Number and Section

§ 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.