(74 days)
Not Found
No
The device description and intended use are purely mechanical, focusing on tubing and connectors for enteral feeding. There is no mention of any computational or analytical capabilities that would suggest AI/ML.
No.
The device is an extension set for enteral feeding tubes, designed to connect existing feeding tubes to delivery systems. It serves as a conduit for nutrition and does not directly provide therapeutic treatment.
No
The device is an extension set for enteral feeding tubes, connecting existing tubes to delivery systems. Its purpose is to facilitate feeding, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical product consisting of flexible PVC tubing and connectors, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use as an extension set for enteral feeding tubes. This involves delivering substances into the body (enteral feeding), not analyzing samples from the body to diagnose conditions.
- Device Description: The description details tubing and connectors for connecting feeding tubes to delivery systems. This aligns with a device used for administering substances, not for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological sample for diagnostic purposes.
- No Mention of Diagnostic Tests: The description of performance studies focuses on design verification and safety, not on the accuracy or performance of a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on the delivery of substances for feeding.
N/A
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.
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.
Product codes
KNT
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Enteral Only Extension Set is a sterile disposable for single patient use only.
The Enteral Only Extension Set is disposable and for single patient use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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 / Address | ||
| of Manufacturing facility | Andrew P. Zeltwanger | |
| Manager, Regulatory Affairs | ||
| Respironics, Inc. | ||
| 1001 Murry Ridge Lane | ||
| Murrysville, PA 15668 | ||
| Phone: 724-387-7442 | ||
| Fax: 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
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.
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.
| enfor
able
1 | 1
। |
| -------------------- | -------- |
|---|
| 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.
2
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)
3
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.
4
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
5
Indications for Use
510(k) Number (if known):
Device Name:
Enteral Only Extension Set
Intended Use/Indications for Use:
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.
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
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