(266 days)
The Pediation Enteral Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. They are intended for nasogastric or orogastric placement, limited to < 30 day placement and not intended for transpylorie placement.
The Pediatric Enteral Feeding Tube Extension sets are used to provide a connection between feeding formula bag and the feeding tube. Extensions sets are offered in non-IV fittings and IV fittings (which have been marked "For enteral feeding only".
The proposed modification to the Pediatric Enteral Feeding Tubes and accessories is to add additional materials that the feeding tube may be made from, i.e., PVC, silicone, and polyurethane. In addition, we offer accessories: an enteral feeding extension set and syringe with non-IV connector. These may be sold with the Enteral Feeding tubes or separately. There is an option of the connectors to be provided as standard IV luer lock or a non-IV connector. In all cases the feeding tube and accessories are marked "For enteral feeding only".
The enteral feeding tubes are provided in various diameters (4, 5, 6.5, 8, 10 Fr) and various lengths. They have an integral female fitting. There are 2 eyelets near the tip of the tube. They have markings along the shaft of the tubing and an integral radiopaque line. They are provided sterile.
The Enteral extension sets are provided in various lengths and various configurations of components.
The provided text describes a 510(k) premarket notification for a Pediatric Enteral Feeding Tube and Accessories. This document focuses on demonstrating substantial equivalence to predicate devices through design comparisons and performance testing based on industry standards, rather than a clinical study comparing the device's performance against specific acceptance criteria in a user setting.
Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details, are not applicable to this type of submission. The submission is primarily about demonstrating that the device meets safety and basic performance standards through bench testing and material comparisons.
Here's a breakdown of the information that can be extracted or inferred from the provided text, with an explanation for the N/A answers:
-
A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria in a typical quantitative performance metric format for a diagnostic device. Instead, it lists performance testing performed in accordance with industry standards. The "reported device performance" is the statement that the device "met the requirements of the industry standards."
Acceptance Criteria (Industry Standard Requirement) Reported Device Performance ISO 594/1 (Gauging of 6% luer conical fittings) Met the requirements BS EN 1615:2000 (Gauging of non-luer conical fittings) Met the requirements BS EN 1615:2000 (Tensile strength and properties of tubing and connectors) Met the requirements BS EN 1615:2000 (Air leakage test of tubing and connectors) Met the requirements BS EN 1615:2000 (Liquid leakage test of tubing and connectors) Met the requirements BS EN 1618:1997 (Separation force) Met the requirements BS EN 1618:1997 (Stress cracking) Met the requirements BS EN 1618:1997 (Unscrewing torque of fitting assembly) Met the requirements BS EN 1618:1997 (Ease of assembly) Met the requirements BS EN 1618:1997 (Resistance to overriding the threads of lugs of the fitting) Met the requirements -
Sample size used for the test set and the data provenance
- Sample Size: Not specified. The testing described is bench testing of physical attributes of the device components, not a clinical test set with patient data.
- Data Provenance: Not applicable, as it's not clinical data. The tests were performed in accordance with industry standards.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth, in the context of device design and materials, is established by adherence to engineering specifications and industry standards for material properties and connector compatibility. It's not a clinical judgment requiring experts to establish diagnostic ground truth.
- Qualifications of Experts: Not applicable.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: None. Adjudication is not relevant for bench testing against engineering standards. The compliance with standards is typically verified by qualified engineers or technicians and documented in test reports.
-
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
- MRMC Study: No. This device is a medical tube and accessories, not an AI-powered diagnostic tool.
- Effect Size: Not applicable.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This device does not involve an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for this device's performance is compliance with published industry standards (ISO, BS EN) for physical and functional properties of medical tubing and connectors. This involves objective measurements against predefined limits set by those standards.
-
The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not use machine learning or AI, so there is no training set in that context.
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How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
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K092628
Page 1 of 3
510(k) Summary Page 1 of 3 12-May-10
MAY 2 0 2010
| Alan Reid | |
|---|---|
| PO Box 660 | |
| 2 South Winchester Street | Tel - 603-357-8733 |
| West Swanzey, NH 03459 | Fax - 603-357-0732 |
| Official Contact: | Alan Reid |
| Proprietary or Trade Name: | Pediatric Enteral Feeding Tube and AccessoriesPediatric Enteral Feeding Tube Extension sets |
| Common/Usual Name: | Feeding Tube or NG /OG Tube |
| Classification Name: | Tubes. Gastrointestinal (and Accessories) |
| Predicate Devices: | NeoDevices - K020005 - Infant Feeding TubesNeoChild -- K082710 - Infant Feeding TubeArgyle / Kendall - K820442 Feeding Tube |
Device Description:
The proposed modification to the Pediatric Enteral Feeding Tubes and accessories is to add additional materials that the feeding tube may be made from, i.e., PVC, silicone, and polyurethane. In addition, we offer accessories: an enteral feeding extension set and syringe with non-IV connector. These may be sold with the Enteral Feeding tubes or separately. There is an option of the connectors to be provided as standard IV luer lock or a non-IV connector. In all cases the feeding tube and accessories are marked "For enteral feeding only".
The enteral feeding tubes are provided in various diameters (4, 5, 6.5, 8, 10 Fr) and various lengths. They have an integral female fitting. There are 2 eyelets near the tip of the tube. They have markings along the shaft of the tubing and an integral radiopaque line. They are provided sterile.
The Enteral extension sets are provided in various lengths and various configurations of components.
Indications for Use:
The Pediatric Enteral Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. They are intended for nasogastric placement, limited to < 30 day placement and not intended for transpyloric placement.
The Pediatric Enteral Feeding Tube Extension sets are used to provide a connection between feeding formula bag and the feeding tube. Extensions sets are offered in non-IV fittings (which have been marked "For enteral feeding only").
Environment of Use:
Hospital or environments where placement of a feeding tube is required.
{1}------------------------------------------------
| rison to Predicate Devices: Attribute | Proposed device | Predicates |
|---|---|---|
| LocationsGeneral | To be placed into the stomach to permit the introduction of fluids as directed by the physician. | To be placed into the stomach to permit the introduction of fluids as directed by the physician.K020005-Infant Feeding Tube |
| Type of placement | Nasogastric or orogastricNot for transpyloric placement. | Nasogastric or orogastric. Not for transpyloric placement.K020005 - Infant Feeding Tube |
| Length of placement | < 30 days | < 30 days - K020005 - Infant Feeding Tube |
| Intended for single patient use | Yes | Yes - K020005-Infant Feeding Tube |
| Prescription required | Yes | Yes - K020005-Infant Feeding Tube |
| Intended population | Neonates, Infants, Pediatrics | Neonates / Infants / Pediatrics -K020005 - Infant Feeding Tube |
| Intended Environment of Use | Hospital or environments where placement of a Feeding tube is required. | Hospital or environments where placement of a Feeding tube is required. K020005 - Infant Feeding Tube |
| Design Features | ||
| Provided in various diameters | 4, 5, 6.5, 8, 10 Fr | Yes-K020005-Infant Feeding Tube (4, 5, 6.5, 8 Fr)Yes-K820442 - Argyle / Kendall (10 Fr) |
| Extension sets for use with enteral feeding tubes to deliver fluids and connector between the feeding tube and the fluid source | Yes, made of PVCAvailable in various lengthsIntended for use with enteral feeding tubes | Yes, made of PVCK890396-Multi-Med enteral feeding setK082710-NeoChild extension set |
| Connector options | Non-IV slip fit female connectionMust be used with the specified syringe with integral mating non-IV connectorStandard IV luer | IV and Non-IVK082710-NeoChild with non-IV connector |
| (2) eyelet holes near tip | Yes | Yes-K020005 - Infant Feeding Tube |
| Radiopaque line | Yes | Yes - K020005 - Infant Feeding Tube |
| Markings along the length of the tubing | Yes | Yes - K020005-Infant Feeding Tube |
| Materials | PVCSiliconePolyurethane | K020005 - Infant Feeding Tube - PVCK082710-NeoChild - silicone, polyurethane |
| Attribute | Proposed device | Predicates |
| Packaging | Feeding tubesExtension SetsSyringe – non-sterile | K020005 - Infant Feeding TubeK890396 – Multi-MedK082710 - NeoChild – Infant Feeding Tube and accessories with non-IV connectorK082710 - NeoChild – Infant Feeding Tube and accessories with non-IV connector |
| Sterile | Offered with and without extension sets of various lengths and connectors | Yes |
| Performance Testing | None under Section 514 | Yes |
| Performance testing was performed in accordance toISO 594/1BS EN 1615:2000BS EN 1618:1997 | Gauging of 6% luer conical fittingsGauging of non-luer conical fittingsTensile strength and properties of tubing and connectorsAir leakage test of tubing and connectorsLiquid leakage test of tubing and connectorsSeparation forceStress crackingUnscrewing torque of fitting assemblyEase of assemblyResistance to overriding the threads of lugs of the fitting | |
| The above listed performance / bench tests were performed and shown to demonstrate that the EnteralFeeding tube, accessories and Enteral extensions sets either met the requirements of the industry standards |
.
K092628
Pug 2013 Page 24 of 67
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510(k) Summary
Page 25 of 67
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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 is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002
Mr. Alan Reid c/o Mr. Paul E. Dryden President ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134-2958
MAY 2 0 2010
Re: K092628
Trade/Device Name: Pediatric Enteral Feeding Tube and Accessories Pediatric Enteral Feeding Tube and Extension sets Regulation Number: 21 CFR §876. 5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 12, 2010 Received: May 14, 2010 . . . .
Dear Mr. Dryden:
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 not the Act or any Federal statutes and regulations administered by other Federal agencies. You must of the new with all the Act's requirements, including, but not limited to: registration and listing (21 CFP Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
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Page 2 –
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/CDRHQffices/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/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 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,
Janine M. Morris
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 Statement
Page 1 of 1
510(k) Number:
Device Name:
Pediatric Enteral Feeding Tube and Accessories Pediatric Enteral Feeding Tube Extension sets
Indications for Use:
The Pediation Enteral Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. They are intended for nasogastric or orogastric placement, limited to < 30 day placement and not intended for transpylorie placement.
The Pediatric Enteral Feeding Tube Extension sets are used to provide a connection between feeding formula bag and the feeding tube. Extensions sets are offered in non-IV fittings and IV fittings (which have been marked "For enteral feeding only".
Prescription Use XX (Part 21 CFR 801 Subpart D)
or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heili Lému
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 26 of 67
§ 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.