MOSS GASTROSTOMY TUBE by MOSS TUBES, INC.

The provided text does not contain information about the acceptance criteria or a study proving the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "Moss Gastrostomy Tube," dated March 22, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

The letter mentions:

Device Name: Moss Gastrostomy Tube
Indications for Use: Used for gastric and proximal duodenal decompression plus duodenal feeding.
Regulatory Class: II, 21 CFR 876.5980
Procode: 78 KNT

However, it does not include:

A table of acceptance criteria and reported device performance.
Sample sizes used for test sets, data provenance, or retrospective/prospective study details.
Number of experts or their qualifications for establishing ground truth.
Adjudication methods.
Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human readers with/without AI assistance.
Results of a standalone algorithm-only performance study.
The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

This document serves as a regulatory clearance document based on substantial equivalence, not a detailed study report with performance metrics.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 1999

Moss Tubes, Inc. c/o Harry Schlakman Attorney at Law 304 Verona Avenue Elizabeth, New Jersey 07208 Re: K990389

Moss Gastrostomy Tube Dated: January 31, 1999 Received: February 8, 1999 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT

Dear Mr. Schlakman:

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). 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,

[signature]

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

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Exhibit IU

510(k) NUMBER (IF KNOWN): _

DEVICE NAME:

Moss Gastrostomy Tube

INDICATIONS FOR USE:

Used for gastric and proximal duodenal decompression plus duodenal 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)

Over-The-Counter-Use (Optional Format 1-2-96)

Damil h. Slegmm
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

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.