The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to less than 30 day placement. Not intended for transpyloric placement.

Device Description

The Infant Feeding Tube is a small diameter tube of various sizes - 5,6, and 8 French, and lengths of 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Infant Feeding Tube." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific acceptance criteria through a clinical study. Therefore, the information requested in the prompt, which is typically found in clinical study reports for devices proving new claims or safety/effectiveness, is largely not applicable or present in this document.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

The document does not specify formal "acceptance criteria" in terms of performance metrics with thresholds (e.g., sensitivity, specificity, accuracy percentages) that would be met by a study. Instead, the "device performance" is demonstrated through a comparison of key attributes to predicate devices, showing that the proposed device shares the same intended use, design features, materials, and sterile packaging.

Attribute	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance
Intended Use	Must be equivalent to predicate devices.	Met (Yes)
To be placed into the stomach to permit the introduction of fluids as directed by the physician. Nasogastric or orogastric placement.	Yes	Yes
Intended for single patient use for a duration of < 30 days	Yes	Yes
Prescription	Yes	Yes
Intended population infants	Yes	Yes
Intended Environment of Use - Hospital or environments where placement of a Feeding tube is required.	Yes	Yes
Design Features	Must be equivalent to predicate devices.	Met (Yes)
Provided in various diameters from 4 - 12 Fr	Yes, 4 - 12 Fr	5,6,8 Fr (within range)
Standard slip fit female luer connector	Yes	Yes
Two (2) eyelet holes near tip	Yes	Yes
Radiopaque line entire length of tubing	Yes	Yes
Markings along the length of the tubing	Yes	Yes
Materials	Must be equivalent to predicate devices.	Met (Yes)
Tubing and Connector - PVC	Yes	Yes
Packaging	Must be equivalent to predicate devices.	Met (Yes)
Sterile	Yes	Yes
Performance (per Section 514)	No specific performance standards under Section 514.	Yes (meets this non-standard)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a clinical study with a "test set" sample size. The filing is based on demonstrating substantial equivalence to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method described as no test set or clinical study was conducted.

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 is a medical device for physical placement, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a sterile physical feeding tube, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The basis for clearance is substantial equivalence to predicate devices already on the market, not a direct demonstration of safety and effectiveness against a ground truth in a clinical study. The "ground truth" in this context is the regulatory acceptance of the predicate devices.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no mention of a training set or its ground truth establishment.

Summary of the Document's Purpose:

The document (510(k) K020005) is a premarket notification to the FDA to demonstrate substantial equivalence of the ProMedic Infant Feeding Tube to previously cleared predicate devices (Vygon Infant Feeding Tubes - K925854, Klein-Baker - Neo-Care Feeding Tube - K861090, Knott Gastric tube - K971354). The study, in this case, is the comparison table itself, which systematically evaluates the proposed device against established predicate devices across various attributes like intended use, design, materials, and packaging. The "proof" is the detailed comparison showing no significant differences that would raise new questions of safety or effectiveness. The FDA's letter (JUL 1 6 2002) confirms this substantial equivalence determination.

Summary

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'JUL 1 6 2002

Non-Confidential Summary of Safety and Effectiveness

	Page 1 of 2April 16, 2002
ProMedic, Inc.6329 W. Waterview Ct.McCordsville, IN 46055	Tel (317) 335-3780Fax (317) 335-9270
Official Contact:	Paul Dryden - President
Proprietary or Trade Name:	Infant Feeding Tube
Common/Usual Name:	Feeding Tube
Classification Name:	Tubes, Gastrointestinal (and Accessories)
Predicate Devices:	Vygon - Infant Feeding Tubes - K925854Klein-Baker - Neo-Care Feeding Tube - K861090Knott Gastric tube - K971354

Device Description: ----------------------------------------------------------------------------------------------------------------------------------------------------------

Intended Use:
Indicated Use --	The Infant Feeding tube is intended to be placed into the stomachto permit the introduction of fluids as directed by the physician.Intended for nasogastric or orogastric placement. Limited to lessthan 30 day placement. Not intended for transpyloric placement.
Environment of Use --	Hospital or environment where placement of a feeding tube isrequired.

rate of the comments of

02005

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Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2 April 16, 2002

Comparison to Predicate Devices: Devices: 10 Comparison 1

Attribute	Proposed device	Predicate Vygon InfantFeeding Tube - K925854
Intended use
To be placed into the stomach topermit the introduction of fluidsas directed by the physician.Nasogastric or orogasticplacement.	Yes	Yes
Intended for single patient use fora duration of < 30 days	Yes	Yes Klein-Baker - Neo-Care Feeding Tube -K861090
Prescription	Yes	Yes
Intended population infants	Yes	Yes
Intended Environment of Use -Hospital or environments whereplacement of a Feeding tube isrequired.	Yes	Yes
Design Features
Provided in various diametersfrom 4 - 12 Fr	5,6,8 Fr	Yes, 4 - 12 Fr
Standard slip fit female luerconnector	Yes	Yes
Two (2) eyelet holes near tip	Yes	Yes
Radiopaque line entire length oftubing	Yes	Yes
Markings along the length of thetubing	Yes	Yes
Materials
Tubing and Connector - PVC	Yes	Yes- Knott Gastric tube -K971354
Packaging
Sterile	Yes	Yes
Performance
None under Section 514	Yes	Yes

Differences between Other Legally Marketed Predicate Devices

There are no significant differences between the intended device and the predicate - Vygon Infant Feeding Tube - K925854, Knott Gastric tube - K971354, and Klein-Baker - Neo-Care Feeding Tube - K861090.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2002

Re: K020005

Trade/Device Name: Infant Feeding Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories

Regulatory Class: II Product Code: 78 KNT Dated: April 16, 2002 Received: April 17, 2002

Dear Mr. Dryden:

Mr. Paul Dryden

6329 W. Waterview Ct.

MCCORDSVILLE IN 46055

President ProMedic, Inc.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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. Ilisting 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 (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:	K020005 (To be assigned)
Device Name:	Infant Feeding Tube
Intended Use:	The Infant Feeding tube is intended to be placedinto the stomach to permit the introduction of fluids asdirected by the physician. Intended for nasogastric ororogastric placement. Limited to less than 30-dayplacement. Not intended for transpyloric placement.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _XX (Per CFR 801.109)

Over-the-counter use__________________________________________________________________________________________________________________________________________________________

Nanay bradon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020005

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.