The Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which reduce the risk of accidental connection of an I.V. system to the enteral system, or the enteral system to an I.V. system.

Device Description

The Enteral Only Extension Set consists of flexible PVC tubing designed to connect existing feeding tubes (nasogastric, gastric, etc.) to various delivery systems including pumps and syringes. The basic set consists of tubing with an enteral connector (catheter tip) and either a luer lock connector or an oral syringe connector. Other variations include the basic sets with the addition of a stop cock or Y site, to allow the clinician to attach other equipment. One configuration (Model 95017-D) utilizes luer lock connections on either end of the extension set, to allow for the connection to existing enteral feeding tubes with luer fittings. Note that in this configuration set does not utilize an oral syringe connection, to minimize the possibility of oral feeding solutions to be delivered into an IV line.

AI/ML Overview

The provided text describes a medical device, the "Enteral Only Extension Set," and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

Instead, the document details a 510(k) submission for regulatory clearance, which focuses on demonstrating substantial equivalence to already legally marketed predicate devices. The "study" mentioned refers to "Design verification tests" which were performed to ensure the device met "required acceptance criteria," but these acceptance criteria are not explicitly defined in terms of specific performance outcomes to be measured.

Here's a breakdown of what is and is not present based on your request:

1. Table of acceptance criteria and the reported device performance:

Not Available: The document states, "All tests were verified to meet the required acceptance criteria," but it does not specify what those acceptance criteria were (e.g., minimum tensile strength, flow rate) nor does it provide a table of the reported numerical performance data from these tests. The tests are general "Design verification tests" resulting from risk analysis and product requirements, rather than a clinical or performance study with defined metrics.

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

Not Applicable/Not Available: This type of information (sample size, country of origin, retrospective/prospective) is typically associated with clinical or performance studies evaluating diagnostic or therapeutic efficacy, which is not what this document describes. The verification tests performed were likely engineering/design tests, not studies on a "test set" of patient data.

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

Not Applicable/Not Available: Ground truth, experts, and their qualifications are relevant to studies where the device's output (e.g., a diagnosis, a measurement) is compared against a definitive standard. This document focuses on the design and manufacturing of an extension set, not on its diagnostic or therapeutic outcome.

4. Adjudication method for the test set:

Not Applicable/Not Available: Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments to establish consensus, which is not relevant to this device's verification.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable/Not Available: This device is an enteral feeding extension set, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI-assisted performance improvements are not relevant here.

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

Not Applicable/Not Available: As above, this is not an AI algorithm.

7. The type of ground truth used:

Not Applicable/Not Available: Because this is a physical medical device (an extension set) and not a diagnostic or AI-driven tool, the concept of "ground truth" (expert consensus, pathology, outcomes data) as typically applied to performance studies does not directly apply to its design verification. The "ground truth" for the verification tests would be defined engineering specifications and functional requirements.

8. The sample size for the training set:

Not Applicable/Not Available: The term "training set" is used for machine learning or AI models. This device is a physical product, not an AI system.

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

Not Applicable/Not Available: See point 8.

In summary:

The provided text from the 510(k) submission describes a design verification process rather than a clinical performance study with specific acceptance criteria related to diagnostic accuracy or clinical outcomes. The "acceptance criteria" referred to are likely engineering and functional specifications for the physical device, which were "met" during the design verification tests. The document aims to establish substantial equivalence to predicate devices based on design and material properties, not on comparative performance metrics in a clinical setting.

Summary

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Image /page/0/Picture/3 description: The image shows the words "TAB 5" on the top left corner and the words "510(K) SUMMARY" on the bottom left corner. The text is in bold and a sans-serif font. The background of the image is a gray and white pattern.

Date of Submission	10 September, 2008	NOV 25 2008
Official Contact / Addressof Manufacturing facility	Andrew P. ZeltwangerManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668Phone: 724-387-7442Fax: 724-387-7490
Proprietary Name	Enteral Only Extension Sets
Common/Usual Name	Tubes, Gastrointestinal (and accessories)
Classification Reference	21 CFR 876.5980
Classification	Class II
Appropriate Classification Panel	Gastroenterology / Urology
Product Code	KNT
Predicate Devices	Vygon Nutrisafe® Extension Tube (K991918)Kangaroo Enteral Feeding Extension Set (K973409)

Intended Use/Indications for Use

The Enteral Only Extension Set is intended for use as an extension set for nasogastric or gastric tube enteral feeding tubes, incorporating safety connectors which eliminate the risk of accidental connection of an I.V. system to the enteral system, or the enteral system to an I.V. system..

Patient Population/Environment of Use

The Enteral Only Extension Set is a sterile disposable for single patient use only.

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K082654 2 of 3
Enteral Only Extension Sets

Substantial Equivalence

This traditional 510(k) submittal demonstrates that the Enteral Only Extension Set is substantially equivalent to the Vygon Nutrisafe® Extension Tube (K991918), and the Kangaroo Enteral Feeding Extension Set (K973409).

Design verification tests were performed on the Enteral Only Extension Set as a result of the risk analysis and the product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the differences between the Enteral Only Extension Set and the predicate enteral set have no impact on the safety and effectiveness of the Enteral Only Extension Set and that all hazards were successfully mitigated.

Device Description

Physical Description and Usage

Descriptions of the different models are shown in Table 11-1. A photograph of a basic Enteral Only Extension Set is shown in Figure 11-1. Engineering drawings for all models are included at the end of Tab 11 - Device Description.

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Model	Description
95017-A	Extension Set w/Catheter Tip and Luer Lock Connector, 60"
95017-B	Extension Set w/Catheter Tip, Stop Cock and Luer Lock Connector, 60"
95017-C	Extension Set w/Catheter Tip, Y-site and Luer Lock Connector, 60"
95017-D	Extension Set w/Male and Female Luer Lock Connectors, 60"

@2008 Respironics Inc.

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Image /page/2/Picture/0 description: The image shows the text "K082 654 313" in a stylized font. Below this text, the words "Enteral Only Extension Sets" are printed in a smaller, simpler font. The numbers and letters are bold and have a handwritten appearance.

95017-E	Extension Set w/Catheter Tip and Luer Lock Connector, 36"
1000364	Extension Set w/ Catheter Tip, Oral Syringe Y-Site, Luer Lock Connector, 60"
1017080	Extension Set w/ Oral Syringe Connector and Catheter Tip, 60"
1018514	Extension Set w/ Oral Syringe Connector and Catheter Tip, 36"
1018516	Extension Set w/ Stop Cock, Oral Syringe Connector and Catheter Tip, 60"
1018517	Extension Set w/ Y-Site, Oral Syringe Connector and Catheter Tip, 60"

Figure 11-1: Enteral Only Extension Set

Image /page/2/Picture/4 description: In the image, there are several wires that are bundled together. There is a tag attached to the wires that has some text on it. The wires are dark in color, and the tag is light in color. The background is dark and blurry.

Material Description

The Enteral Only Extension Sets are manufactured from polyvinyl chloride (PVC) tubing. The connectors and adaptors are manufactured of several plastics: PVC, acrylonitrile butadiene styrene (ABS), polyethylene (PE), polypropylene (PP), and polycarbonate (PC). All materials have been evaluated in accordance with ISO 10993-1 Biological Evaluation of Medical Devices -- Part 1: Evaluation and Testing. A biocompatibility assessment of the materials is included in Section 15 of this submittal.

(End of tab)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 2008

Mr. Andrew P. Zeltwanger Manager, Regulatory Affairs Respironics, Inc. Sleep and Home Respiratory Group 1740 Golden Mile Highway MONROEVILLE PA 15146

K082654 Re:

Trade/Device Name: Enteral Only Extension Set Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: September 10, 2008 Received: September 12, 2008

Dear Mr. Zeltwanger:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jorgu M. Whang

Joyce M. Whang, Ph.D. Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Enteral Only Extension Set

Intended Use/Indications for Use:

Patient Population/Environment of Use:

The Enteral Only Extension Set is disposable and for single patient use only.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Reeves

of Reproductive. Abdominal a

Page

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.