Intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication during the time period that gastric decompression is required. The device is intended for patients with age of two-year and older.

Device Description

The product is a double lumen sump tube available in 5 sizes, 10Fr – 18Fr, and lengths of 36 – 48 inches. The device is equipped with a Multi-functional port to allow alternating use for gastric decompression (via a suction connector) or delivery of fluids, including irrigation, nutritional supplements, and medication via a syringe or feeding set equipped with a female ENFit connector.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Salem Sump™ Dual Lumen Stomach Tube with Multi-functional Port). It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing. This type of document typically does not include the detailed information requested in the prompt regarding acceptance criteria, study methodologies for performance evaluation, or clinical effectiveness studies in the way an AI/ML device submission would.

Therefore, for almost all categories, the answer will be that the information is not provided in this document.

However, I can extract what is present related to non-clinical testing and general acceptance.

Here's a breakdown based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding reported performance for a specific clinical or diagnostic metric in the way an AI/ML device would. Instead, it describes various non-clinical tests performed to ensure the device maintains safety and effectiveness equivalent to the predicate device, especially with the addition of the new ENFit connector.

Non-Clinical Tests Mentioned for the ENFit Connector (Implied Acceptance):

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Fluid leakage	Passed (tested to demonstrate performance)
Stress cracking	Passed (tested to demonstrate performance)
Resistance to separation (axial)	Passed (tested to demonstrate performance)
Resistance to separation (unscrewing)	Passed (tested to demonstrate performance)
Resistance to overriding	Passed (tested to demonstrate performance)
Disconnection from unscrewing	Passed (tested to demonstrate performance)
Dimensional analysis	Passed (tested to demonstrate performance)
Misconnection assessment	Demonstrated incompatibility with other medical devices (to reduce risk)
Durability (tensile properties)	Evaluated for durability (implies passing relevant thresholds)
Biocompatibility (ISO 10993-1:2009)	Demonstrated biological safety
Stability testing (accelerated aging)	Evaluated key performance properties in support of expiration date
Usability and human factors	Conducted as part of design (implies positive outcome)

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

Sample Size for Test Set: Not specified. The document refers to non-clinical tests on the device components, not a test set of patient data.
Data Provenance: Not applicable, as no patient data or clinical study data is referenced for evaluation. The tests are non-clinical, likely conducted in a lab environment.

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

Not applicable. The ground truth, in this context, would be established by engineering specifications and standards for device performance, not expert review of medical images or patient outcomes.

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

Not applicable, as no expert adjudication of a test set is mentioned.

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 not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device.

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

For the non-clinical tests, the "ground truth" is defined by the established engineering standards, regulatory requirements (e.g., ISO 10993-1:2009, AAMI/CN3:2014 (PS) Part 3), and internal design specifications for device performance and safety (e.g., for fluid leakage, tensile strength, biocompatibility).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question doesn't apply.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three heads, representing the department's focus on health and human well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 8, 2015

Covidien Wei Zhao, M.D. Senior Director, Regulatory Affairs 15 Hampshire Street Mansfiled. MA 02048

Re: K150711

Trade/Device Name: Salem Sump™ Dual Lumen Stomach Tube with Multi-functional Port Regulation Number: 21 CFR$ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF, FEG Dated: September 3, 2015 Received: September 4, 2015

Dear Wei Zhao,

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. 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.

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.

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Page 2 - Wei Zhao, M.D.

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150711

Device Name

Salem Sump™ Dual Lumen Stomach Tube with Multi-functional Port

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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2.0 510(k) Summary

Salem Sump™ Dual Lumen Stomach Tube with Multi-functional Port

In accordance with section 513(i) of the SMDA and as defined in 21CFR Part 807.92 this summary is submitted by:

Covidien 15 Hampshire Street Mansfield, MA 02048 Date Prepared: January 18, 2015

a. Contact Person

Wei Zhao Senior Director, Regulatory Affairs Covidien Telephone: (508) 261-8404 Fax: (508) 261-8461

b. Name of Medical Device

Common Name: Tube, double lumen for intestinal decompression and/or intubation

U.S. FDA Classification Product Code: FEG, PIF

U.S. Regulation Description: Gastrointestinal tube and accessories, 21 CFR 876.5980

Proprietary / Trade Name: Salem Sump™ Dual Lumen Stomach Tube with Multi-functional Port

c. Identification of Legally Marketed Device(s)

Next Generation Salem Sump, K040388

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d. Device comparison summary

Device Comparison Summary
Predicate Device	Proposed Device
Device Name	Next Generation SalemSump with Multi-portConnector	Salem Sump™ Dual LumenStomach Tube with Multi-Functional Port (with ENFitconnector)
Intended use	Intended for gastricdecompression and delivery offluids, including irrigation,nutritional supplements, andmedication during the timeperiod that gastricdecompression is required.	Intended for gastricdecompression and delivery offluids, including irrigation,nutritional supplements, andmedication during the timeperiod that gastricdecompression is required. Thedevice is intended for patientswith age of two-year and older.
Sterility	Sterile by gamma irradiation	Sterile by gamma irradiationand ethylene oxide
Technological Characteristics	The device is a gastric sumptube which utilizes amultifunctional port to allowalternating use for gastricdecompression or delivery offluids, including irrigation,nutritional supplements, andmedication. The connectionfor delivery of fluidssupports multiple types ofdevices and connectors.	The device is a gastric sumptube which utilizes amultifunctional port to allowalternating use for gastricdecompression or delivery offluids, including irrigation,nutritional supplements, andmedication. The connectionfor delivery of fluids is via amale ENFit connector.
Design	The product is a doublelumen sump tube available in5 sizes, 10Fr – 18Fr, andlengths of 36 – 48 inches.The device is equipped witha Multi-functional port toallow alternating use forgastric decompression (via asuction connector) ordelivery of fluids, includingirrigation, nutritionalsupplements, and medicationvia a catheter tip syringe or afeeding set with a stepconnector.	The product is a doublelumen sump tube available in5 sizes, 10Fr – 18Fr, andlengths of 36 – 48 inches.The device is equipped witha Multi-functional port toallow alternating use forgastric decompression (via asuction connector) ordelivery of fluids, includingirrigation, nutritionalsupplements, and medicationvia a syringe or feeding setequipped with a femaleENFit connector.
Materials / ChemicalComposition	Sump Tube● Polyvinyl chloride	Sump Tube● Polyvinyl chloride

(PVC)• Barium Sulfate• print ink	(PVC)• Barium Sulfate• print ink
Multi-functional port• Polycarbonate• Polyethylene• Polypropylene• Cyanoacrylate adhesive• Silicone rubber• Silicone lubricant• Print ink	Multi-functional port• Polycarbonate• Polyethylene• Polypropylene• Cyanoacrylate adhesive• Silicone rubber• Silicone lubricant• Print ink• Copolyester

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Discussion of technological differences e.

The Salem Sump™ Dual Lumen Stomach Tube with Multi-functional Port are intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication during the time period that gastric decompression is required. The primary technological difference is the incorporation of the new ENFit connector which is compliant to AAMI/CN3:2014 (PS) Part 3. This connector is part of an industry wide effort to address misconnections by adopting a uniform connector that has been engineered to meet the objective of AAMI/ANSI/ISO 80369-1, small-bore connectors for liquids and gases in healthcare applications - part 1: general requirements. The additional changes implemented in manufacturing technologies are incidental to the primary change, and do not alter device performance.

f. Discussion of Nonclinical testing
- The following risk management activities were executed to identify the potential hazards, evaluate their risks and develop the risk mitigation methods:
  - ENFit connector: Risk management report o
  - Proposed device: Design Failure Modes and Effects Analysis (FMEA) and risk o analysis.
- Biocompatibility testing in accordance with ISO 10993-1:2009. Biological Evaluation of ● medical Devices- Part 1: Evaluation and Testing has demonstrated the biological safety of parts of the medical device which may indirectly contact the patient, and is consistent with FDA "Draft Guidance for Industry and FDA staff, Use of international Standard ISO 10993 'Biological Evaluation of medical Devices Part 1: Evaluation and Testing,"' issued on April 23, 2013. Similar testing had been conducted for the predicate device.

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Stability testing of the proposed device evaluated the key performance properties of the feeding set after accelerated aging in support of the expiration date which will be applied to the device.
Usability and human factors testing was conducted as part of the design of the ENFit . connector.
Device tensile properties were evaluated for its durability.
. The following tests were performed to demonstrate the physical and functional performance of the ENFit connector:
- fluid leakage o
- stress cracking о
- resistance to separation from axial load O
- resistance to separation from unscrewing O
- resistance to overriding о
- disconnection from unscrewing O
- dimensional analysis o
Misconnection assessment of ENFit connector and suctioning port was conducted to . prove the incompatibility of the ENFIt small bore connector to other medical devices to reduce the risk of misconnection.
g. Clinical testing

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

h. Conclusions

This information provided within this pre-market notification demonstrates that the modified Salem Sump™ Dual Lumen Stomach Tube with Multi-Functional Port with ENFit Connectors is as safe, as effective, and performs as well as or better than the legally marketed device, therefore I find the subject device to be substantially equivalent to the predicate device. The addition of the ENFit connector, which is compliant with AAMI/CN3:2014 (PS) Part 3 is intended to improve device performance by addressing the risk of misconnections.

End of Summary

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.