The subject of this 510(k) is a modified proximal connector for Abbott Nutrition enteral feeding sets. The proximal connector connects the tubing of the enteral feeding set to the source of the nutrition (i.e., the container of the enteral nutritional formula). The modified design is the Safety Screw Connector and is compliant with the new AAMI/ISO Standard 80369-1 (Small-bore connectors for liguids and gases in healthcare applications – Part 1: General Requirements). This same design is being used for currently marketed competitive enteral nutrition sets.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the "Safety Screw Connector," a component of enteral feeding sets. It describes the device, its intended use, and the performance tests conducted to demonstrate substantial equivalence to existing devices.

Here's an analysis of the acceptance criteria and study data based on the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Non-interconnectable Characteristics	Compliance with ANSI/AAMI/ISO 80369-1:2010 for preventing misconnection with other types of connectors.	"Mechanical test for verifying non-interconnectable characteristics of Safety Screw Connector and other connectors (ANSI/AAMI/ISO 80369-1:2010)" was conducted. The conclusion states, "The new design reduces the risk of unintentional misconnection to another type of tube." This implies the connector met the standard's requirements for non-interconnectability with other types of connectors.
Delivery Accuracy & Feeding System Performance	The device should not negatively impact the accurate delivery of liquid nutrition formulas or water.	"Delivery accuracy and feeding system performance assessment testing of Safety Screw Connector" was conducted. The conclusion states, "Performance testing showed that the new designs are equivalent to currently marketed devices." This implies that the device maintained delivery accuracy and overall feeding system performance comparable to existing systems.
Biocompatibility	The device materials should be biocompatible and not cause adverse biological reactions when in contact with fluids.	"Biocompatibility testing for the Safety Screw Connector and the RTH Adapter Cap" was conducted. While no specific results are detailed, the general conclusion that "new designs are equivalent to currently marketed devices" and the statement "the new connector does not raise new questions of safety and effectiveness" suggest the biocompatibility criteria were met.
Tensile Strength (Bond Junction)	The bond between the Safety Screw Connector and the tubing should be strong enough to withstand expected forces without separation.	"Tensile strength testing for the bond junction between the Safety Screw Connector and tubing" was conducted. Although no specific numerical result is provided, the conclusion "new designs are equivalent to currently marketed devices" indicates that the tensile strength of the bond junction met the required performance standards for safety and effectiveness, similar to predicate devices.
Overall Safety and Effectiveness	The device should be as safe and effective as legally marketed predicate devices and introduce no new safety concerns.	The document explicitly states: "The new design reduces the risk of unintentional misconnection to another type of tube. The risk analysis showed that the new connector does not raise new questions of safety and effectiveness. Performance testing showed that the new designs are equivalent to currently marketed devices." This is the overarching acceptance criterion, concluding that the device is substantially equivalent to predicate devices, thus meeting safety and effectiveness expectations.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each test (mechanical, delivery accuracy, biocompatibility, tensile strength). Nor does it specify the data provenance (e.g., country of origin, retrospective or prospective) for these performance tests. It implies these tests were conducted as part of the device development and validation by Abbott Nutrition/Abbott Laboratories.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the given text. The tests described (mechanical, delivery accuracy, biocompatibility, tensile strength) are typically objective engineering and laboratory tests, not requiring expert "ground truth" in the way a diagnostic AI might. The "ground truth" for these tests would be the established specifications and standards (e.g., ANSI/AAMI/ISO 80369-1:2010), and the results are quantitatively measured and compared against these benchmarks.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The performance tests are objective laboratory and engineering tests, not involving subjective interpretation or adjudication by multiple human observers.

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

An MRMC study is not applicable as this device is a physical connector, not an AI-powered diagnostic or assistive tool for human readers. Therefore, no information on human reader improvement with or without AI assistance is provided or relevant.

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

This question is not applicable as the device is a physical connector, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the performance tests was based on established engineering standards and specifications (e.g., ANSI/AAMI/ISO 80369-1:2010) against which the device's measured performance was compared. For biocompatibility, the ISO 10993 series would typically serve as the ground truth framework. For delivery accuracy and tensile strength, the ground truth would be the performance of legally marketed predicate devices and internal/industry specifications deemed safe and effective.

8. The Sample Size for the Training Set

This question is not applicable. The Safety Screw Connector is a physical medical device, not a machine learning or AI model. Therefore, there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for this type of device.

Summary

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K113719 Page 1 of

Abbott Nutrition · Abbott Laboratories 510(k) Premarket Notification

APR 2 0 2012

510(k) Summary

In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for the Safety Screw Connector is provided below.

Device Common Name: Gastrointestinal tubes and accessories

Device Proprietary Name: Safety Screw Connector

510(k)#

K113719

Submitter:

Abbott Nutrition Abbott Laboratories 3300 Stelzer Road Columbus, OH 43219-3034

Contact:

Elizabeth M. Zola, PharmD Associate Director, Regulatory Affairs Abbott Nutrition Abbott Laboratories Phone: 614-624-3316 Fax: 614-727-3316 Email: elizabeth.zola@abbott.com

Classification Regulation:

21 CFR 876.5980

Panel:

Gastroenterology/Urology

Product Code:

KNT

Indication for Use:

The sets are intended to deliver liquid nutrition formulas or water to an enteral access device (a feeding tube).

CONFIDENTIAL INFORMATION

This document includes confidential and proprietary business information that is exempt from disclosure under the U.S. Freedom of Information Act (FOIA). Prior to any FOIA response, contact the submitter (Abort Laboratories) for a pre-release review pursuant 21 CFR § 20.61.

Page 18

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KIJ3719

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Abbott Nutrition Abbott Laboratories 510(k) Premarket Notification

Device Description:

The modified design is the Safety Screw Connector and is compliant with the new AAMI/ISO Standard 80369-1 (Small-bore connectors for liguids and gases in healthcare applications – Part 1: General Requirements). This same design is being used for currently marketed competitive enteral nutrition sets.

This bundled 510(k) is a modification of the following three Class 2 nutrition devices:

K943240 Flexiflo® Six Enteral Nutrition Pump Set: KNT, Class 2, 876.5980, . Gastroenterology/Urology (currently marketed as the Patrol® Pump Set with Piercing Pin).
K915735 Flexiflo® Quantum Enteral Pump Sets and Enteral Nutrition Containers: KNT, . Class 2. 876.5980. Gastroenterology/Urology (currently marketed as two versions; Flexiflo@ Quantum Pump Set with Piercing Pin and the Flexiflo® Quantum Pump Set with Piercing Pin and Flush Bag)
PREAMENDMENT Gravity Feeding Sets: KNT, Class 2, 876.5980, . Gastroenterology/Urology

Performance Data:

The following tests were conducted in support of the substantial equivalence:

Mechanical test for verifying non-interconnectable characteristics of Safety Screw t Connector and other connectors (ANSI/AAMI/ISO 80369-1:2010)
Delivery accuracy and feeding system performance assessment testing of Safety Screw . Connector
Biocompatibility testing for the Safety Screw Connector and the RTH Adapter Cap �
Tensile strength testing for the bond junction between the Safety Screw Connector and ● tubing

Substantial Equivalence:

The Abbott Nutrition enteral feeding devices with the Safety Screw Connector are substantially equivalent to commercially marketed Abbott Nutrition sets in terms of principle of operation and intended use. The new design reduces the risk of unintentional misconnection to another type of

CONFIDENTIAL INFORMATION

This document includes confidential and proprietary business information that is exempt from disclosure under the U.S. Freedom of Information Act (FOIA). Prior to any FOLA response, contact the submitter (Abort Laboratories) for a pre-release review pursuant 21 CFR § 20.61.

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K113719 Pzgc 3of3

Abbott Nutrition Abbott Laboratories 510(k) Premarket Notification

tube. The risk analysis showed that the new connector does not raise new questions of safety and effectiveness. Performance testing showed that the new designs are equivalent to currently marketed devices.

CONFIDENTIAL INFORMATION

This document includes confidential and proprietary business information that is exempt from disclosure under the I his dobanient information Act (FOIA). Prior to any FOTA response, contact the submitter (Abort Laboratories) for a pre-release review pursuant 21 CFR § 20.61.

Page 20

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Elizabeth M. Zola, PharmD Associate Director, Regulatory Affairs Abbott Nutrition Abbott Laboratories 3300 Stelzer Road COLUMBUS OH 43219

APR 2 0 2012

Re: K113719

Trade/Device Name: Safety Screw Connector Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: March 15, 2012 Received: March 16, 2012

Dear Dr. Zola:

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 Act. The Act. The Act. The Act. The A 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing 0011); "Ital an 1001); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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, Ph.D.

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 Statement 4.0

510{k} Number (if known):

Device Name: Safety Screw Connector

Indications For Use: .

The sets are intended to deliver liquid nutrition formulas or water to an enteral access device (a feeding tube).

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, andUrological Devices
510(k) Number	K113719
Page 1 of	1

CONFIDENTIAL INFORMATION

This document includes confidential and proprietary business information that is exempt from disclosure under the U.S. Freedom of Information Act (FOIA). Prior to any FOIA response, contact the submitter (Abbott Laboratories) for a pre-release review pursuant 21 CFR § 20.61.

Page 17

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.