PEF TUBE

• K Number: K071579
• Device Name: PEF TUBE
• Manufacturer: N.M. BEALE CO. INC.
• Date Cleared: 2007-11-20 ( 165 days)
• Product Code: KNT , FDA
• Regulation Number: 876.5980
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: N/A

Intended Use

For use in achieving simultaneous access to the stomach and duodenum to allow fluid sampling in procedures such as pancreatic exocrine function testing.

Device Description

The PEF Tube consists of a soft, dual-lumen tube with a proximal Y-connector that allows separate access to each of the 2 lumens. One lumen opens distally in the stomach; the second lumen opens into the duodenum.

AI/ML Overview

The N.M. Beale Company, Inc. PEF Tube is a gastrointestinal tube designed for simultaneous access to the stomach and duodenum for fluid sampling, particularly in pancreatic exocrine function testing. The performance testing for this device focused on demonstrating substantial equivalence to a predicate device and/or meeting pre-determined acceptance criteria for safety and effectiveness.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Tensile Testing	Performance data demonstrated that the N.M. Beale Co., Inc. PEF Tube is substantially equivalent to the predicate device and/or met pre-determined acceptance criteria.
Safety and Effectiveness	The PEF Tube meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness.
Material/Design Properties	(Specific numerical acceptance criteria for tensile strength, elongation, etc., are not provided in the document. The document only states that "tensile testing" was performed and that the device met criteria.)

Note: The provided document states that "tensile testing" was performed, but it does not specify the exact numerical acceptance criteria for this testing (e.g., minimum tensile strength in Newtons, or maximum elongation). It only indicates that the device "met pre-determined acceptance criteria."

Study Information

1. Sample size used for the test set and the data provenance:

   • The document does not specify the sample size for the tensile testing or its
     provenance (e.g., country of origin, retrospective/prospective).

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

   • This is not applicable as the performance testing for the PEF Tube
     involved physical tensile testing, not interpretation of data requiring expert
     ground truth.

3. Adjudication method for the test set:

   • This is not applicable for tensile testing.

4. 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:

   • No MRMC or AI-related study was indicated for this medical device. The
     device is a physical gastrointestinal tube, not an AI or imaging device.

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

   • This is not applicable. The device is a physical gastrointestinal tube,
     not an algorithm.

6. The type of ground truth used:

   • For tensile testing, the "ground truth" would be established by
     engineering standards and specifications for the material and design of
     gastrointestinal tubes, verified through calibrated testing equipment. The
     document does not explicitly state the specific standards or
     specifications used but implies that predefined criteria were met.

7. The sample size for the training set:

   • This is not applicable. The device undergoes physical performance
     testing, not machine learning training.

8. How the ground truth for the training set was established:

   • This is not applicable.

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.