The Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is intended for gastric decompression and administration of nutrition, fluids and medication. The device is intended for patients with age of two and older.

Device Description

The Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is a double-lumen tube made of PVC used for naso/orogastric drainage and feeding. The larger (main) lumen is for feeding and drainage, while the smaller lumen draws in outside air to moderate the amount of suction at the drainage eyes. The device contains an ISO 80369-3 compliant ENFit connector which is inserted into the main lumen after decompression is no longer required to administer enteral fluids, including enteral nutrition, hydration and medication. It is a single use device which is provided sterilized via EO sterilization.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: the Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets novel clinical acceptance criteria for an AI/CAD system or a diagnostic tool that requires robust clinical performance studies.

Therefore, the information requested in your prompt regarding acceptance criteria for an AI study, sample sizes, expert ground truth adjudication, MRMC studies, standalone algorithm performance, or training set details cannot be found in this document. The requirements you listed are typically applicable to software as a medical device (SaMD) or devices that rely heavily on algorithmic or diagnostic performance for their intended use.

This 510(k) summary focuses on the physical and functional characteristics of a physical device (a stomach tube) and its safety and efficacy as compared to a previously cleared device. The "acceptance criteria" here would be largely non-clinical performance benchmarks and adherence to established standards for medical tubing and connectors.

Here's how to interpret the document in the context of what is provided:

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

The document doesn't present a formal table of acceptance criteria with quantitative results in the way you might expect for an AI study. Instead, it lists the non-clinical performance data (testing) performed and broadly states that the results "show that the modified device continues to meet the requirements of the product specifications and supports the determination of substantial equivalence."

The "acceptance criteria" are implied by the standards and the successful completion of the listed tests:

Acceptance Criteria (Implied by Standards/Tests)	Reported Device Performance (Summary)
Compliance with EN 1615:2000 (Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing)	Device complies with this standard.
Compliance with EN 1618:1997 (Catheters other than intravascular catheters. Test methods for common properties)	Device complies with this standard.
Compliance with ISO 80369-1:2010 (Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements)	Device complies with this standard.
Compliance with ISO 80369-3:2016 (Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications)	Device complies with this standard.
Compliance with ISO 80369-20:2015 (Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods)	Device complies with this standard.
Compliance with ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process)	Device complies with this standard (related to biocompatibility).
Functional Verification (e.g., proper operation for intended use)	Testing showed functional performance.
Occlusion Verification (e.g., tube does not easily occlude)	Testing showed acceptable performance.
Liquid/Fluid Leakage (e.g., no leaks)	Testing showed no unacceptable leakage.
Patency Verification (e.g., remains open for fluid flow)	Testing showed patency.
Tensile Strength (e.g., resistance to breaking under tension)	Testing showed acceptable tensile strength.
Resistance to separation from axial load	Testing showed acceptable resistance to separation.
Resistance to separation from unscrewing	Testing showed acceptable resistance to separation.
Resistance to overriding	Testing showed acceptable resistance to overriding.
Disconnection by unscrewing	Testing showed acceptable performance.
Stress Cracking (e.g., resistance to cracking under stress)	Testing showed resistance to stress cracking.
Dimension verification (e.g., correct sizes, given configurations)	Dimensions verified to be within specification.
Flow Rate (e.g., fluids pass through at expected rates)	Testing showed acceptable flow rates.
Simulated Gastric Indwell (e.g., maintains integrity in gastric environment)	Testing showed stability during simulated indwell.
Biocompatibility Evaluation (e.g., non-toxic, non-irritating)	Device is biocompatible.
Shelf Life (2 years) (e.g., maintains integrity and function over 2 years)	Device maintains function and integrity for 2 years.

The "reported device performance" for each of these is broadly summarized as "met requirements" or "complies," demonstrating "substantial equivalence."

Regarding points 2-9 of your prompt:

These points are not applicable to this 510(k) submission because it is for a physical medical device (Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection), not an AI/CAD system or a diagnostic device.

2. Sample sized used for the test set and the data provenance: Not applicable. Testing was likely done on a sample of manufactured devices, but not on "data" in the sense of patient images or clinical records.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for a physical tube involves manufacturing specifications and physical testing, not expert clinical interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is for an AI/CAD system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is based on engineering specifications, material properties, and performance standards for medical tubing and connectors (e.g., ISO, EN standards).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a physical medical device, not a software or AI-based diagnostic tool. The "acceptance criteria" and "study" described align with the physical and functional performance testing required for a Class II device like a stomach tube.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 7, 2019

Cardinal Health Alexis Erazo Principal Regulatory Affairs Specialist 777 West Street Mansfield, MA 02048

Re: K190923

Trade/Device Name: Salem Sump Dual Lumen Stomach Tube with ENFit Connection Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF, FEG Dated: October 7, 2019 Received: October 8, 2019

Dear Alexis Erazo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 may publish further announcements concerning your device in the Federal Register.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Martha W. Betz, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190923

Device Name

Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K190923 Page 1 of 3

510(k) Summary Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection

Preparation date:

November 4, 2019

Submitter Information:

Alexis Erazo Principal Regulatory Affairs Specialist Cardinal Health 777 West Street, Mansfield, MA 02048 Phone: 508.618.3727 Email: alexis.erazo@cardinalhealth.com

Name of Medical Device:

Trade Name:	Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection
Common Name:	Tubes, gastrointestinal
Classification Name:	Gastrointestinal tube and accessories
Regulation Number:	21 CFR 876.5980
Product Code:	PIF; FEG
Class:	II

Identification of Predicate Device:

510(k) Number	K150711
Device Description	Salem Sump Dual Lumen Stomach Tube with Multi-Functional Port
Submitter	Covidien

Identification of Reference Device:

510(k) Number	K935781
Device Description	Argyle Salem Sump Tube Anti-Reflex Valve Insertion Tray
Submitter	Sherwood Medical Co.

Identification of Reference Device:

510(k) Number	K150084
Device Description	Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™Polyurethane (PU) Neonatal and Pediatric Feeding Tubeswith ENFit connector
Submitter	Covidien

Device Description:

The Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is a double-lumen tube made of PVC used for naso/orogastric drainage and feeding. The larger (main) lumen is

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for feeding and drainage, while the smaller lumen draws in outside air to moderate the amount of suction at the drainage eyes. The device contains an ISO 80369-3 compliant ENFit connector which is inserted into the main lumen after decompression is no longer required to administer enteral fluids, including enteral nutrition, hydration and medication. It is a single use device which is provided sterilized via EO sterilization.

The Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is available in the following configurations:

6Fr x 24in ●
. 8Fr x 24in
10Fr x 36in
. 12Fr x 48in
. 14Fr x 48in
16Fr x 48in ●
18Fr x 48in

Intended Use/Indications for Use:

Product Comparison Summary:

The proposed Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection has the same intended use, indications for use and similar fundamental technological characteristics and as compared to the predicate Salem Sump Dual Lumen Stomach Tube with Multi-Functional Port (K150711). Verification testing provided demonstrates that the technological characteristics differences to the Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection do not raise new questions of safety and efficacy than that of the predicate K150711. The test results demonstrate that the proposed device is as safe and effective as the legally marketed predicate device.

Non-Clinical Performance Data:

Laboratory testing was completed to support substantial equivalence between the modified device and the current device. The modified device was evaluated to show compliance to the standards requirements (listed below) as well as performance characteristics related to the modification of the device.

EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and ● their connectors - Design and testing
EN 1618:1997 Catheters other than intravascular catheters. Test methods for . common properties
. ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare . applications - Part 3: Connectors for enteral applications

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Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection Traditional 510(k) Pre-Market Notification

. ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
. ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

The following testing was conducted to demonstrate that the device continues to meet the requirements of the product specifications and supports the determination of substantial equivalence.

. Functional Verification
Occlusion Verification ●
Liquid/Fluid Leakage .
Patency Verification .
Tensile Strength
Resistance to separation from axial load ●
. Resistance to separation from unscrewing
. Resistance to overriding
. Disconnection by unscrewing
. Stress Cracking
Dimension verification ●
Flow Rate ●
Simulated Gastric Indwell ●
Biocompatibility Evaluation ●
Shelf Life (2 years) ●

The results of the testing show that the modified device continues to meet the requirements of the product specifications and supports the determination of substantial equivalence.

Clinical Data:

Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence.

Conclusion:

The proposed Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection has the same indications for use, intended use and similar fundamental technological characteristics and as compared to the predicate Salem Sump Dual Lumen Stomach Tube with Multi-Functional Port (K150711). Verification testing demonstrates that the difference in technological characteristics between the K157011 predicate and the proposed Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection do not raise new questions of safety and efficacy. In addition, test results demonstrate that the proposed device is as safe and effective as the legally marketed predicate device. Based on the above evaluation, the proposed Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is substantially equivalent to the predicate Salem Sump Dual Lumen Stomach Tube with Multi-Functional Port (K150711).

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.