(129 days)
The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician Intended for nasogastric or orogastric placement Lumited to < 30 day placement Not intended for transpyloric placement
The proposed modification to Infant Feeding Tube and accessories is to add additional materials that the feeding tube may be made from, 1 e , silicone and polyurethane In addition, we offer accessories an enteral extension set and syringe with non-IV connector These may be sold with the Feeding tubes or separately There is an option of the connectors being standard IV luer lock or a special non-IV connector which was cleared under K072756
The feeding tubes are a small diameter tube of various diameters, 4, 5, and 8 French, and various lengths They have an integral female fitting There are 2 eyelets near the tup of the tube They have markings along the shaft of the tubing and an integral radiopaque line They are provided sterile We will offer a non-sterile syringe with the appropriate mating, non-IV connector as part of the package, which was also cleared under K072756
The provided text is a Premarket Notification 510(k) Summary for the SafeChild Infant Feeding Tube and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with specific acceptance criteria and outcome metrics.
Therefore, the document does not contain information on an acceptance criteria table, reported device performance, sample size for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for "the device."
The entire document describes the device, its indications for use, and then compares it to existing predicate devices to show it is substantially equivalent. The "Performance" section within the comparison to predicate devices explicitly states "None under Section 514," which refers to performance standards rather than a clinical or analytical performance study. This indicates that a study demonstrating unique acceptance criteria and performance for this specific device was not required or provided for this 510(k) submission.
The comparison table provided in the document is used to demonstrate substantial equivalence to predicate devices, not to report on an independent performance study against acceptance criteria.
{0}------------------------------------------------
Non-Confidential Summary of Safety and Effectivenes IN 2 3 2009
Page 1 of 5 15-Sep-08
| NeoChild LLC4605 N StilesOklahoma City, OK 73105 | Tel 888-887-6428Fax 405-813-2905 |
|---|---|
| Official Contact | Rhett Bolen - Operations and QA Manager |
| Proprietary or Trade Name | SafeChild Infant Feeding Tube and Accessories |
| Common/Usual Name | Feeding Tube or NG /OG Tube |
| Classification Name | Tubes, Gastrointestinal (and Accessories) |
| Predicate Devices | NeoChild - Infant Feeding Tubes - K052903NeoChild - Infant feeding Tube with non-IVconnector - K072756Klein Baker (Utah) – K945012 and K861090 - NutriCath SiliconeFeeding Tube and enteral feeding tube extension setVygon - K925854 - NutriSafe Polyurethane Feeding TubeNeoChild - K003854 Intravascular Administration Sets |
Device Description
The proposed modification to Infant Feeding Tube and accessories is to add additional materials that the feeding tube may be made from, 1 e , silicone and polyurethane In addition, we offer accessories an enteral extension set and syringe with non-IV connector These may be sold with the Feeding tubes or separately There is an option of the connectors being standard IV luer lock or a special non-IV connector which was cleared under K072756
The feeding tubes are a small diameter tube of various diameters, 4, 5, and 8 French, and various lengths They have an integral female fitting There are 2 eyelets near the tup of the tube They have markings along the shaft of the tubing and an integral radiopaque line They are provided sterile We will offer a non-sterile syringe with the appropriate mating, non-IV connector as part of the package, which was also cleared under K072756
Indications for Use
The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician Intended for nasogastric or orogastric placement Lumited to < 30 day placement Not intended for transpyloric placement
Available in PVC. Silicone or Polyurethane
Environment of Use
Hospital, home, or environments where placement of a feeding tube is required
$\leftarrow$
{1}------------------------------------------------
SafeChıld Enteral Feeding Tube and Accessories
-- / !"
.. '
Premarket Notification 5100
Section 5 – 510(k) Summary
Non-Confidential Summary of Safety and Effectivenes
C102738
56-08
| 1000 | |
|---|---|
| 1 | |
| icate | |
| - | |
| the country of | |
| to | |
| I | |
| Comparison to Predicate DevicesAttribute | Proposed device with modification | Predicates |
|---|---|---|
| IndicationsGeneral | To be placed into the stomach to permit theintroduction of fluids as directed by the physician | To be placed into the stomach to permit the introduction offluids as directed by the physicianK052903 - Infant Feeding TubeK072756-Infant Feeding Tube and accessories with non-IVconnector |
| Type of placement | Nasogastric or orogastricNot for transpyloric placement | Nasogastric or orogastricNot for transpyloric placementK052903 - Infant Feeding TubeK072756-Infant Feeding Tube and accessories with non-IVconnector |
| Length of placement | < 30 days | < 30 daysK052903-Infant Feeding TubeK072756- Infant Feeding Tube and accessories with non-IVconnector |
| Intended for single patient use | Yes | YesK052903 Infant Feeding TubeK072756- Infant Feeding Tube and accessories with non-IVconnector |
| Prescription | Yes | YesK052903-Infant Feeding TubeK072756-Infant Feeding Tube and accessories with non-IVconnector |
| Intended population | Neonates, Infants, Pediatrics | Infants / PediatricsK052903 Infant Feeding TubeK072756-Infant Feeding Tube and accessories with non-IVconnectorNeonatesK945012 - Klein Baker (Utah) NutriCath |
| Attribute | Proposed device with modification | Predicates |
| Intended Environment of Use | Hospital, home, or environments where placement of aFeeding tube is required | Hospital, home or environments where placement of aFeeding tube is requiredK052903 - Infant Feeding TubeK072756 - Infant Feeding Tube and accessories with non-IV connector |
| Design FeaturesProvided in various diameters from4 - 8 Fr | 4, 5, 6, 5, 8 Fr | 5, 6, 5, 8 FrK052903 - Infant Feeding TubeK072756 - Infant Feeding Tube and accessories with non-IV connector |
| 4 FrK925854 - Vygon NutriSafe for 4 Fr size | ||
| Extension sets for use with enteralfeeding tubes to deliver fluids andconnector between the feeding tubeand the fluid source | YesMade of PVCAvailable in various lengthsIntended for use with enteral feeding tubes | YesK003854 - NeoChild IV extension set |
| Connector options | Non-IV slip fit female connectionMust be used with the NeoChild syringe with integralmating non-IV connectorStandard IV luer | YesK945012 - Klein Baker (Utah) NutriCath with extension setNon-IVK072756 - Infant Feeding Tube and accessories with non-IV connectorStandard slip fit female luerK052903 - Infant Feeding Tube |
| Two (2) eyelet holes near tip | Yes | YesK052903 - Infant Feeding Tube |
| Radiopaque line | Yes | YesK052903 - Infant Feeding Tube |
| Markings along the length of thetubing | Yes | YesK052903 - Infant Feeding Tube |
| Attribute | Proposed device with modification | Predicates |
| Materials | ||
| Tubing | PVC | K052903 – Infant Feeding TubeK072756 – Infant Feeding Tube and accessories with non-IV connector |
| SiliconePolyurethane | Klem Baker (Utah) – K945012 and K861090 NutriCathVygon – K925854 - NutriSafe | |
| Packaging | ||
| Sterile | YesFeeding tubes | YesK052903 – Infant Feeding TubeK072756 – Infant Feeding Tube and accessories with non-IV connector |
| Non-sterile | Extension SetsYesSyringe with integral non-IV Connector | K003854 – IV extensions setsK945102 – Klein Baker (Utah) NutriCathYesK072756 – Infant Feeding Tube and accessories with non-IV connector |
| Offered with and without extensionsets of various lengths andconnectors | Yes | K072756 – Infant Feeding Tube and accessories with non-IV connector |
| PerformanceNone under Section 514 | Yes | Yes |
{2}------------------------------------------------
SafeChild Enteral Feeding Tube and Accessories
Premarket Notification 510(
Non-Confidential Summary of Safety and Effectiveness
15-Sep-08
Lageos 01
{3}------------------------------------------------
Premarket Notification 510(
SafeChıld Enteral Feeding Tube and Accessories
1 - 1
on-Confidential Summary of Safety and Effectiveness
K082710
Page 4 of 5
{4}------------------------------------------------
Non-Confidential Summary of Safety and Effectiveness Page 5 of 5 15-Sep-08
Differences between Other-Legally Marketed Predicate Devices
There are no significant differences between the intended device and the predicates -
- NeoChild K052903 -Infant Feeding Tubes, ●
- NeoChıld K072756 Infant feeding Tube with non-IVconnector, .
- Klein Baker (Utah) K945012 and K861090 NutriCath Silicone Feeding Tube and . Enteral Feeding tube extension set,
- Vygon K925854 NutriSafe Polyurethane Feeding Tube, and .
- NeoChıld K003854 Intravascular Admınıstration (extension) Sets .
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle or bird with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird image. The text is in all capital letters and is relatively small compared to the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2009
Mr Rhett Bolen Operations / QA Manager NeoChild LLC 4605 North Stiles Avenue OKLAHOMA CITY OK 73105
Re K082710
Trade/Device Name SafeChild Enteral Feeding Tube and Accessories Regulation Number 21 CFR $876 5980 Regulation Name Gastrointestinal tube and accessories Regulatory Class Class II Product Code KNT Dated January 6, 2009 Received January 12, 2009
Dear Mr Bolen
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 pror 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 Reguster
{6}------------------------------------------------
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 os 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 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notrication" (21 CFR 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 Manufactures, 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/cdrb/industry.suppot/index.html.
Sincerely yours,
Laura B. Merrill
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Indications for Use Statement
Page 1 of 1
| 510(k) Number: | Ko82710 (To be assigned) |
|---|---|
| Device Name: | SafeChild Enteral Feeding tube and accessories |
Indications for Use:
The Infant Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician Intended for nasogastric or orogastric placement Limited to < 30 day placement Not intended for transpyloric placement
There are accessory extension sets which are used with the Feeding tubes
The Feeding tubes are available in different materials - PVC, Silicone or Polyurethane
| 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)
Helen Leem
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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.