Five configurations of enteral delivery sets: Standard Bag, Standard SpikeRight® PLUS, DualFlo Bag/SpikeRight PLUS, DualFlo Bag/Bag and Gravity Set for administering liquid nutrition or hydration to an enteral access device (feeding tube).

AI/ML Overview

This document is a 510(k) premarket notification for the Compat® Enteral Delivery Pump Set, which is a medical device. The information provided heavily emphasizes regulatory compliance and substantial equivalence to a predicate device, rather than detailed studies proving performance against acceptance criteria in the typical sense of a clinical trial or algorithm validation study.

Based on the provided text, the device is an enteral delivery pump set, and the "acceptance criteria" and "study" are primarily focused on bench testing to demonstrate that the redesigned connector (ENFit) is safe and performs comparably to the predicate device's connector or meets specified standards.

Here's the breakdown of what can be extracted from the provided text regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

It's challenging to create a direct table of acceptance criteria in the format often seen for algorithm performance (e.g., sensitivity, specificity, AUC). Instead, the document lists various performance tests conducted, and the implication is that the device met the acceptance criteria for each of these tests, demonstrating substantial equivalence. The document does not explicitly state the specific pass/fail values for each test, only that the tests were performed.

Acceptance Criteria (Inferred from Tests Performed)	Reported Device Performance (Inferred as 'Met Criteria')
Risk Assessment: FMECA conducted	Risk assessed, criticalities analyzed
ENFit Component Verification: Tested for proper function	Components verified (presumably, passed verification)
ENFit Bond Strength: Measured	Bond strength met requirements (presumably)
PGLOCK Administration Validation: Tested	Validation completed (presumably, passed validation)
Tensile Properties (ASTM D638-10): Plastics tested	Tensile properties met standard (presumably)
Performance with/without Reference Connectors:
- Falling drop positive pressure liquid leakage	No leakage (presumably, met criteria)
- Stress cracking	No stress cracking (presumably, met criteria)
- Resistance to separation from axial load	Resistance met requirements (presumably)
- Resistance to separation from unscrewing	Resistance met requirements (presumably)
- Resistance to overriding	Resistance met requirements (presumably)
- Disconnection by unscrewing	Disconnection as expected (presumably)
- Falling drop positive pressure liquid leakage after 20 cycles	No leakage (presumably, met criteria)
Enteral Connector Misconnection Assessment: Studied	Misconnection risk assessed and managed (presumably, acceptable)
Failure Modes and Effects Analysis (FMEA): Conducted	Failure modes analyzed, effects mitigated (presumably, acceptable)
Risk Analysis: Conducted	Risks analyzed and managed (presumably, acceptable)
Human Factors Testing: Performed	Human factors considered and addressed (presumably, acceptable)
Biocompatibility Testing (ISO 10993):
- Part 5: In Vitro Cytotoxicity	Passed cytotoxicity tests
- Part 10: Irritation and Delayed-Type Hypersensitivity (Intracutaneous - rabbits)	Passed irritation tests
- Part 10: Irritation and Delayed-Type Hypersensitivity (Sensitization - guinea pig)	Passed sensitization tests
Flow Rate Testing (ENFit vs. Step Connector):	ENFit flow rate equals or exceeds step connector flow rate

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

Sample Size: The document does not specify exact sample sizes for each bench test. For example, for "falling drop positive pressure liquid leakage" or "bond strength testing," a specific number of samples would have been tested, but this detail is not provided.
Data Provenance: The studies are "bench testing," meaning they were conducted in a laboratory setting. There is no mention of country of origin for the data; it would typically be conducted by the manufacturer or a contract lab. The studies are by nature prospective in the sense that they were designed and executed to test the device's performance attributes after its design.

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

This concept is not applicable to this type of device and study. The "ground truth" for verifying mechanical and material properties (e.g., bond strength, flow rate, biocompatibility) is established by adherence to specified standards (e.g., ASTM, ISO) and physical measurements, not by expert consensus or interpretation of images/data. The experts involved would be engineers, material scientists, and toxicologists conducting the tests.

4. Adjudication Method

This concept is not applicable. Adjudication is typically used in clinical studies or studies involving human judgment (e.g., reading medical images) to resolve discrepancies or establish a consensus ground truth. For bench testing of a physical device, results are objective measurements against defined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret outputs, often with and without AI assistance. The Compat® Enteral Delivery Pump Set is a physical delivery system, not a diagnostic tool requiring human interpretation in this manner.

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

No, a standalone algorithm performance study was not done. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests is derived from objective physical and chemical measurements against established industry standards and regulatory requirements (e.g., ISO 10993 for biocompatibility, ASTM D638-10 for tensile properties, and performance benchmarks for flow rates and leakage). For example, "ground truth" for bond strength would be the measured force required to break the bond, compared against a predefined acceptable limit.

8. The Sample Size for the Training Set

This concept is not applicable. This device is not an AI/ML algorithm that requires a "training set." The development process involved engineering design, material selection, and iterative physical prototyping and testing, not data training.

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

This concept is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is an abstract symbol of three human profiles facing right, stacked on top of each other.

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

September 4, 2014

Nestle HealthCare Nutrition, Inc. % M.W. (Andy) Anderson, Ph.D., RAC Senior Principal Advisor, Regulatory Affairs and Quality Systems Regulatory & Clinical Research Institute, Inc. (RCRI) 5353 Wayzata Boulevard. Suite 505 Minneapolis, MN 55416

Re: K140947

Trade/Device Name: Compat® Enteral Delivery Pump Set Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF Dated: August 15, 2014 Received: August 18, 2014

Dear M.W. (Andy) Anderson,

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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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/ResourcesforYou/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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4.0 Indication for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

N/A K140947

Device Name

Compat® Enteral Delivery Pump Set

Indications for Use (Describe)

The Compat® Enteral Delivery Pump Sets are intended to deliver liquid nutition formulas or hydration to an enteral access device (a feeding tube).

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Traditional 510(k) Summary (21 CFR § 807.92)

Submitter:	Nestlé HealthCare Nutrition, Inc.
Contact:	Thomas A. Dold
Date Prepared:	29 August 2014
Establishment RegistrationNumber:	2110851
Trade Name:	Compat® Enteral Delivery Pump Sets
Common Name:	Tubes, gastrointestinal and accessories
Device Classification:	Gastrointestinal Tubes with Enteral Specific Connectors
Class:	II
Product Code:	PIF
Regulation:	21 CFR 876.5980
Classification Panel:	Gastroenterology/Urology
Predicate Device(s):	COMPAT DualFlo® Enteral Delivery Pump Set withSpikeRight Piercing Spike and 1000 mL Water BagK080340
Device Description:	Five configurations of enteral delivery sets: StandardBag, Standard SpikeRight® PLUS, DualFlo Bag/SpikeRightPLUS, DualFlo Bag/Bag and Gravity Set for administeringliquid nutrition or hydration to an enteral access device(feeding tube).
Intended Use:	The Compat Enteral Delivery Pump Sets are intended todeliver liquid nutrition formulas or hydration to anenteral access device (a feeding tube)
Technological Characteristics:	Single-use enteral delivery sets consist of PVC tubing,formula/water bag, drip chamber, ABS SpikeRight PLUSand ENFit connectors with roller or slide clamps.
Performance Testing (Bench):	The following performance testing was conducted onthe Compat Enteral Delivery Administration Sets:● Risk Assessment of the Administration Setsincluding Failure Modes and Effects CriticalityAnalysis (FMECA)

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ENFit component verification testing ●
. ENFit bond strength testing
PGLOCK Administration Validation Testing
ASTM D638-10: Standard Test Method for Tensile Properties of Plastics
Performance testing with and without reference connectors:
- Falling drop positive pressure liquid leakage o
- Stress cracking O
- Resistance to separation from axial load O
- Resistance to separation from unscrewinq O
- Resistance to overriding O
- Disconnection by unscrewing o
- Falling drop positive pressure liquid leakage o after 20 cycles
. Enteral Connector Misconnection Assessment Study
Failure Modes and Effects Analysis (FMEA)
Risk Analysis
Human Factors Testinq
Biocompatibility Testing (ISO 10993)
- o Part 5: Tests for Invitro Cytotoxicity
- o Part 10: Tests for Irritation and Delayed-Type Hypersensitivity — Intracutaneous Study (rabbits)
- o Part 10: Tests for Irritation and Delayed-Type Hypersensitivity – Sensitization Study (guinea pig)
. Flow Rate Testing to assure ENFit flow rate equals or exceeds step connector flow rate

Performance Testing (Animal): None provided

Performance Testing (Clinical): None provided
Substantial Equivalence The Compat Enteral Delivery Administration Sets are substantially equivalent to the approved Nestlé Rationale: Healthcare Nutrition administration sets except for the replacement of the distal AAMI ID54 ("Christmas tree" or "step") connector with the ENFit connector tested in accordance with ISO 80369-1.

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.